ID

36655

Description

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

Keywords

Versions (1)
  1. 5/28/19 5/28/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 28, 2019

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License

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

English

Eligibility

1 forms  
  1. StudyEvent: ODM
    1. Eligibility
Elimination Criteria During the Study
Description

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.
Description

Pharmaceutical Preparations, Vaccination

Data type

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.)
Description

Immunosuppressive Agents, Chronic

Data type

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.
Description

Vaccination, Concomitant Agent

Data type

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.
Description

Hib-MenCY-TT vaccine; Meningococcal Vaccine

Data type

boolean

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

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

Data type

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.
Description

Immunoglobulins, Blood Product

Data type

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)
Description

Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0201388
Contradictions to Subsequent Vaccination
Description

Contradictions to Subsequent Vaccination

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

Vaccination, Hypersensitivity

Data type

boolean

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

Vaccination, Hypersensitivity

Data type

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.
Description

Encephalopathies, Administration of vaccines, Post

Data type

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.
Description

Nervous system disorder, Progressive disease

Data type

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.
Description

Body Temperature, Administration of vaccine, Post

Data type

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.
Description

Collapse, Administration of vaccine, Post

Data type

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.
Description

Persistent Crying, Administration of vaccine, Post

Data type

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.
Description

Seizures, Administration of vaccine, Post

Data type

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.
Description

Vaccines, Component, Hypersensitivity

Data type

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.
Description

Vaccines, Component, Hypersensitivity

Data type

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.
Description

Latex allergy

Data type

boolean

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

Vaccines, Component, Hypersensitivity

Data type

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).
Description

Acute disease, During, Administration of vaccine

Data type

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.
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
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Similar models

Eligibility

1 forms
  1. StudyEvent: ODM
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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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