0 Evaluaciones
ID

24715

Descripción

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline 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 This form contains the PRE STUDY CONTACT VISIT

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Versiones (1)
  1. 14/8/17 14/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 de agosto de 2017

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Licencia

Creative Commons BY-NC 3.0
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    GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

    Inglés

    GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

    1 formularios  
    General Information
    Descripción

    General Information

    Alias
    UMLS CUI-1
    C1508263
    Age
    Descripción

    Age

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0001779
    Visit
    Descripción

    Visit

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0545082
    Timing
    Descripción

    Timing

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0449243
    Sampling time point
    Descripción

    Sampling time point

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0427352
    Subject Number
    Descripción

    PREVIOUS STUDY : 100478 (DTPW-HBV=HIB-MENAC-TT-011) Same subject number as primary study

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Informed Consent
    Descripción

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    Informed Consent Date
    Descripción

    Informed Consent Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    Demographics
    Descripción

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Center number
    Descripción

    Center number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Birth
    Descripción

    Date of Birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descripción

    Gender

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Descripción

    Ethnicity

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race
    Descripción

    Race

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Other, specify:
    Descripción

    Race other

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0034510
    PROTOCOL REQUIRED CONCOMITANT VACCINATION
    Descripción

    PROTOCOL REQUIRED CONCOMITANT VACCINATION

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0042196
    Have the MMR incentive vaccine been administered ?
    Descripción

    administered

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0065828
    MMR INCENTIVE
    Descripción

    MMR INCENTIVE

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0065828
    UMLS CUI [1,2]
    C0021147
    Please complete only if different from visit date:
    Descripción

    different from visit date

    Tipo de datos

    date

    Adverse Events
    Descripción

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
    Descripción

    Pain at injection site

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2700396
    UMLS CUI [1,3]
    C0030193
    INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
    Descripción

    Drowsiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013144
    UMLS CUI [1,2]
    C0522510
    INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
    Descripción

    Irritability / fussiness

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0522510
    INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
    Descripción

    Loss of appetite

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1971624
    UMLS CUI [1,2]
    C0522510
    INTENSITY FOR NON-SOLICITED SYMPTOMS
    Descripción

    NON SOLICITED SYMPTOMS

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
    Descripción

    CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0877248
    OUTCOME
    Descripción

    OUTCOME

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1705586
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    Similar models

    GSK non-inferiority of Tritanrix Hepatitis B PRE STUDY CONTACT VISIT NCT00290303

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI [1])
    Visit
    Item
    Visit
    integer
    C0545082 (UMLS CUI [1])
    Timing
    Item
    Timing
    date
    C0449243 (UMLS CUI [1])
    Sampling time point
    Item
    Sampling time point
    text
    C0427352 (UMLS CUI [1])
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    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
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    Code List
    Ethnicity
    CL Item
    American Hispanic or Latino (1)
    CL Item
    Not American Hispanic or Latino (2)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    African Heritage / African American (1)
    CL Item
    American Indian or Alaskan Native (2)
    CL Item
    Asian - Central/South Asian Heritage (3)
    CL Item
    Asian - East Asian Heritage (4)
    CL Item
    Asian - Japanese Heritage (5)
    CL Item
    Asian - South East Asian Heritage (6)
    CL Item
    Native Hawaiian or Other Pacific Islander (7)
    CL Item
    White - Arabic / North African Heritage (8)
    CL Item
    White - Caucasian / European Heritage (9)
    CL Item
    Other, specify: (10)
    Race other
    Item
    Other, specify:
    text
    C0034510 (UMLS CUI [1])
    Item Group
    PROTOCOL REQUIRED CONCOMITANT VACCINATION
    C2347852 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    administered
    Item
    Have the MMR incentive vaccine been administered ?
    boolean
    C0065828 (UMLS CUI [1])
    MMR INCENTIVE
    Item
    MMR INCENTIVE
    boolean
    C0065828 (UMLS CUI [1,1])
    C0021147 (UMLS CUI [1,2])
    different from visit date
    Item
    Please complete only if different from visit date:
    date
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Item
    INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
    integer
    C0877248 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    Pain at injection site
    Code List
    INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
    CL Item
    Absent (0)
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    Item
    INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
    integer
    C0013144 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Drowsiness
    Code List
    INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
    CL Item
    Behavior as usual (0)
    CL Item
    Drowsiness easily tolerated (1)
    CL Item
    Drowsiness that interferes with normal activity (2)
    CL Item
    Drowsiness that prevents normal activity (3)
    Item
    INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
    integer
    C0022107 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Irritability / fussiness
    Code List
    INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
    CL Item
    Behavior as usual (0)
    CL Item
    Crying more than usual / no effect on normal activity (1)
    CL Item
    Crying more than usual / interferes with normal activity (2)
    CL Item
    Crying that cannot be comforted / prevents normal activity (3)
    Item
    INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
    integer
    C1971624 (UMLS CUI [1,1])
    C0522510 (UMLS CUI [1,2])
    Loss of appetite
    Code List
    INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
    CL Item
    Appetite as usual (0)
    CL Item
    Eating less than usual / no effect on normal activity (1)
    CL Item
    Eating less than usual / interferes with normal activity (2)
    CL Item
    Not eating at all (3)
    Item
    INTENSITY FOR NON-SOLICITED SYMPTOMS
    integer
    C0518690 (UMLS CUI [1])
    NON-SOLICITED SYMPTOMS
    Code List
    INTENSITY FOR NON-SOLICITED SYMPTOMS
    CL Item
    Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. = interfering with everyday activities. (1)
    CL Item
    Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
    CL Item
    Severe: An adverse event which prevents normal, everyday activities (3)
    CL Item
    (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (4)
    CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
    boolean
    C0013230 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    OUTCOME
    integer
    C1705586 (UMLS CUI [1])
    OUTCOME
    Code List
    OUTCOME
    CL Item
    Recovered / Resolved (1)
    CL Item
    Recovering / Resolving: Subject is recovering at the time she/he completes the study or at the time she/he withdraws from study. (2)
    CL Item
    Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up; in case of death AEs that are not the cause of death. (3)
    CL Item
    Recovered with sequelae / Resolved with sequelae (4)
    CL Item
    Fatal: AE is the cause of death (only applicable for SAE reports) (5)
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