ID

36931

Descripción

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Palabras clave

Versiones (1)
  1. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Inglés

Eligibility

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility
Elimination Criteria During the Study
Descripción

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Descripción

Pharmaceutical Preparations, Vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042196
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Descripción

Immunosuppressive Agents, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine(s) and ending 30 days after.
Descripción

Vaccination, Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Administration of a Hib or a meningococcal vaccine not foreseen by the study protocol since birth and for a period up to one month after the booster vaccine dose.
Descripción

Hib-MenCY-TT vaccine; Meningococcal Vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2352428
UMLS CUI [2]
C0700144
Intercurrent Neisseria meningitidis disease and intercurrent Haemophilus influenzae type b disease.
Descripción

Neisseria meningitidis, Intercurrent disease; Haemophilus influencae type b, Intercurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027575
UMLS CUI [1,2]
C0277557
UMLS CUI [2,1]
C0121772
UMLS CUI [2,2]
C0277557
Administration of immunoglobulins and/or any blood products during the study period.
Descripción

Immunoglobulins, Blood Product

Tipo de datos

boolean

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

Immunologic Deficiency Syndromes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201388
History of measles, mumps, rubella or varicella.
Descripción

Measles, Medical History; Mumps, Medical History; Rubella, Medical History, Varicella zoster, Medical History

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0262926
Previous vaccination against measles, mumps, rubella or varicella.
Descripción

Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0026780
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0035920
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C0740380
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0205156
Previous booster vaccination with Hib vaccine since the last visit of the primary phase.
Descripción

Haemophilus influenzae b vaccines, During, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3653328
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
revious vaccination with a meningococcal vaccine since the last visit of the primary phase.
Descripción

Meningococcal vaccine, During, Clinical Trials

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700144
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to booster..
Descripción

Measles, Exposure to; Exposure to Mumps; Exposure to Rubella; Exposure to varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025007
UMLS CUI [1,2]
C0332157
UMLS CUI [2]
C2720520
UMLS CUI [3]
C0262619
UMLS CUI [4]
C2732622
Contradictions to Subsequent Vaccination
Descripción

Contradictions to Subsequent Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C1301624
Anaphylactic reaction following the administration of vaccine.
Descripción

Vaccination, Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0020517
Hypersensitivity reaction to the vaccine.
Descripción

Vaccination, Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0020517
Encephalopathy (not due to another identifiable cause). This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTPa vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
Descripción

Encephalopathies, Administration of vaccines, Post

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085584
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.
Descripción

Nervous system disorder, Progressive disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1335499
Fever ≥ 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
Descripción

Body Temperature, Administration of vaccine, Post

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
Descripción

Collapse, Administration of vaccine, Post

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0344329
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of vaccination.
Descripción

Persistent Crying, Administration of vaccine, Post

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Seizures with or without fever occurring within 3 days of vaccination.
Descripción

Seizures, Administration of vaccine, Post

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
History of hypersensitivity to any component of the vaccine, including diphtheria toxoid.
Descripción

Vaccines, Component, Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0020517
Hypersensitivity to any component of the vaccine including diphtheria toxoid. As with other vaccines, the administration of Meningitec® should be postponed in subjects suffering from acute febrile illness.
Descripción

Vaccines, Component, Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0020517
History of allergic disease or reactions to latex.
Descripción

Latex allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0577628
History of hypersensitivity to any component of the vaccine, including tetanus toxoid.
Descripción

Vaccines, Component, Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0020517
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. rectal temperature <38°C, axillary temperature <37.5°C).
Descripción

Acute disease, During, Administration of vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2368628
Fever at the time of vaccination - Rectal temperature ≥38°C, axillary ≥37.5°C.
Descripción

Fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
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Similar models

Eligibility

1 formularios
  1. StudyEvent: ODM
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Pharmaceutical Preparations, Vaccination
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Immunosuppressive Agents, Chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (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])
C0205191 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine(s) and ending 30 days after.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Hib-MenCY-TT vaccine; Meningococcal Vaccine
Item
Administration of a Hib or a meningococcal vaccine not foreseen by the study protocol since birth and for a period up to one month after the booster vaccine dose.
boolean
C2352428 (UMLS CUI [1])
C0700144 (UMLS CUI [2])
Neisseria meningitidis, Intercurrent disease; Haemophilus influencae type b, Intercurrent disease
Item
Intercurrent Neisseria meningitidis disease and intercurrent Haemophilus influenzae type b disease.
boolean
C0027575 (UMLS CUI [1,1])
C0277557 (UMLS CUI [1,2])
C0121772 (UMLS CUI [2,1])
C0277557 (UMLS CUI [2,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or imunodeficient condition based on medical history and physical examination (no laboratory testing is required)
boolean
C0201388 (UMLS CUI [1])
Measles, Medical History; Mumps, Medical History; Rubella, Medical History, Varicella zoster, Medical History
Item
History of measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0026780 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0035920 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0740380 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
Measles, Vaccination, Previous; Mumps, Vaccination, Previous; Rubella, Vaccination, Previous; Varicella zoster, Vaccination, Previous
Item
Previous vaccination against measles, mumps, rubella or varicella.
boolean
C0025007 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0026780 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0035920 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0740380 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Haemophilus influenzae b vaccines, During, Clinical Trials
Item
Previous booster vaccination with Hib vaccine since the last visit of the primary phase.
boolean
C3653328 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Meningococcal vaccine, During, Clinical Trials
Item
revious vaccination with a meningococcal vaccine since the last visit of the primary phase.
boolean
C0700144 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Measles, Exposure to; Exposure to Mumps; Exposure to Rubella; Exposure to varicella
Item
Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to booster..
boolean
C0025007 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C2720520 (UMLS CUI [2])
C0262619 (UMLS CUI [3])
C2732622 (UMLS CUI [4])
Item Group
Contradictions to Subsequent Vaccination
C0042196 (UMLS CUI-1)
C1301624 (UMLS CUI-2)
Vaccination, Hypersensitivity
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Vaccination, Hypersensitivity
Item
Hypersensitivity reaction to the vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Encephalopathies, Administration of vaccines, Post
Item
Encephalopathy (not due to another identifiable cause). This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTPa vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
boolean
C0085584 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Nervous system disorder, Progressive disease
Item
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.
boolean
C0027765 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Body Temperature, Administration of vaccine, Post
Item
Fever ≥ 40.5°C (rectal temperature) within 48 hours of vaccination not due to another identifiable cause.
boolean
C0005903 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Collapse, Administration of vaccine, Post
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
boolean
C0344329 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Persistent Crying, Administration of vaccine, Post
Item
Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of vaccination.
boolean
C2721683 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Seizures, Administration of vaccine, Post
Item
Seizures with or without fever occurring within 3 days of vaccination.
boolean
C0036572 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Vaccines, Component, Hypersensitivity
Item
History of hypersensitivity to any component of the vaccine, including diphtheria toxoid.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Vaccines, Component, Hypersensitivity
Item
Hypersensitivity to any component of the vaccine including diphtheria toxoid. As with other vaccines, the administration of Meningitec® should be postponed in subjects suffering from acute febrile illness.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Latex allergy
Item
History of allergic disease or reactions to latex.
boolean
C0577628 (UMLS CUI [1])
Vaccines, Component, Hypersensitivity
Item
History of hypersensitivity to any component of the vaccine, including tetanus toxoid.
boolean
C0042210 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Acute disease, During, Administration of vaccine
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. rectal temperature <38°C, axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Fever
Item
Fever at the time of vaccination - Rectal temperature ≥38°C, axillary ≥37.5°C.
boolean
C0015967 (UMLS CUI [1])
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