ID

20888

Descripción

Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response; ODM derived from: https://clinicaltrials.gov/show/NCT00197158

Link

https://clinicaltrials.gov/show/NCT00197158

Palabras clave

Versiones (1)
  1. 25/3/17 25/3/17 -
Subido en

25 de marzo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Hepatitis B NCT00197158

Inglés

Eligibility Hepatitis B NCT00197158

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female >= 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the subject.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
free of obvious health problems as established by medical history and clinical examination before entering into the study.
Descripción

Health Problem Free of | Medical History | examination; clinical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0332296
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1456356
if the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Descripción

Gender Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0427780
UMLS CUI [7]
C0042196
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
Descripción

Investigational New Drugs | Drugs, Non-Prescription | Vaccine OTC - Over The Counter | Vaccine Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C2709201
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C0008976
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, greater than or equal to 0.5 mg/kg/day. inhaled and topical steroids are allowed.)
Descripción

Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone U/day | Prednisone equivalent U/day | inhaled steroids | topical steroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0001617
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C3242703
UMLS CUI [5,3]
C0456683
UMLS CUI [6]
C2065041
UMLS CUI [7]
C2064827
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Descripción

Vaccine | Vaccine Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1301732
previous vaccination against hepatitis b
Descripción

Hepatitis B vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474232
history of hepatitis b infection
Descripción

Hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
known exposure to hepatitis b within the previous 6 weeks
Descripción

Hepatitis B Exposure to

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332157
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Descripción

Immunosuppression | Immunologic Deficiency | Immunosuppression Suspected | Immunologic Deficiency Suspected | HIV Infections

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
a family history of congenital or hereditary immunodeficiency.
Descripción

Immunodeficiency congenital Family history | Immunologic Deficiency Hereditary Family history

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Descripción

Hypersensitivity Exacerbated Caused by Vaccine Component | Allergic Reaction Exacerbated Caused by Vaccine Component

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0042210
UMLS CUI [1,5]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0042210
UMLS CUI [2,5]
C1705248
acute disease at the time of enrolment. (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. oral temperature < 37.5°c (99.5°f) /
Descripción

Disease | Disease Moderate | Disease Severe | Fever | Vaccines | minor (disease) | Diarrhea | Upper Respiratory Infection Mild | Disorder characterized by fever Low grade | Oral temperature Degrees Celsius | Oral temperature Degrees fahrenheit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0015967
UMLS CUI [5]
C0042210
UMLS CUI [6]
C1446899
UMLS CUI [7]
C0011991
UMLS CUI [8,1]
C0041912
UMLS CUI [8,2]
C2945599
UMLS CUI [9,1]
C0743841
UMLS CUI [9,2]
C1282907
UMLS CUI [10,1]
C1532216
UMLS CUI [10,2]
C0439237
UMLS CUI [11,1]
C1532216
UMLS CUI [11,2]
C0456628
axillary temperature <37.5°c (99.5°f).
Descripción

Axillary temperature

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1531924
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Descripción

Lung function abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Lung function abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0476405
UMLS CUI [2]
C0232090
UMLS CUI [3]
C0086565
UMLS CUI [4]
C0151746
UMLS CUI [5,1]
C0476405
UMLS CUI [5,2]
C0205191
UMLS CUI [6,1]
C0232090
UMLS CUI [6,2]
C0205191
UMLS CUI [7,1]
C0086565
UMLS CUI [7,2]
C0205191
UMLS CUI [8,1]
C0151746
UMLS CUI [8,2]
C0205191
UMLS CUI [9]
C0031809
UMLS CUI [10]
C0022885
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. pregnant or lactating female.
Descripción

Immunoglobulins | Blood product | Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
Descripción

Pregnancy, Planned | Contraceptive methods Discontinue Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1301732
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Similar models

Eligibility Hepatitis B NCT00197158

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
a male or female >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Health Problem Free of | Medical History | examination; clinical
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018684 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Gender Childbearing Potential Absent | Female Sterilization | Postmenopausal state | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative | Vaccination
Item
if the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
C0042196 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Vaccine OTC - Over The Counter | Vaccine Clinical Trial
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C2709201 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone U/day | Prednisone equivalent U/day | inhaled steroids | topical steroids
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, greater than or equal to 0.5 mg/kg/day. inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0032952 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0032952 (UMLS CUI [5,1])
C3242703 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C2065041 (UMLS CUI [6])
C2064827 (UMLS CUI [7])
Vaccine | Vaccine Planned
Item
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hepatitis B vaccination
Item
previous vaccination against hepatitis b
boolean
C0474232 (UMLS CUI [1])
Hepatitis B
Item
history of hepatitis b infection
boolean
C0019163 (UMLS CUI [1])
Hepatitis B Exposure to
Item
known exposure to hepatitis b within the previous 6 weeks
boolean
C0019163 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Immunosuppression | Immunologic Deficiency | Immunosuppression Suspected | Immunologic Deficiency Suspected | HIV Infections
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
Immunodeficiency congenital Family history | Immunologic Deficiency Hereditary Family history
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Hypersensitivity Exacerbated Caused by Vaccine Component | Allergic Reaction Exacerbated Caused by Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1705248 (UMLS CUI [1,5])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C1705248 (UMLS CUI [2,5])
Disease | Disease Moderate | Disease Severe | Fever | Vaccines | minor (disease) | Diarrhea | Upper Respiratory Infection Mild | Disorder characterized by fever Low grade | Oral temperature Degrees Celsius | Oral temperature Degrees fahrenheit
Item
acute disease at the time of enrolment. (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. oral temperature < 37.5°c (99.5°f) /
boolean
C0012634 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0015967 (UMLS CUI [4])
C0042210 (UMLS CUI [5])
C1446899 (UMLS CUI [6])
C0011991 (UMLS CUI [7])
C0041912 (UMLS CUI [8,1])
C2945599 (UMLS CUI [8,2])
C0743841 (UMLS CUI [9,1])
C1282907 (UMLS CUI [9,2])
C1532216 (UMLS CUI [10,1])
C0439237 (UMLS CUI [10,2])
C1532216 (UMLS CUI [11,1])
C0456628 (UMLS CUI [11,2])
Axillary temperature
Item
axillary temperature <37.5°c (99.5°f).
boolean
C1531924 (UMLS CUI [1])
Lung function abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Lung function abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Procedures
Item
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0476405 (UMLS CUI [1])
C0232090 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0151746 (UMLS CUI [4])
C0476405 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0232090 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0086565 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0151746 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0031809 (UMLS CUI [9])
C0022885 (UMLS CUI [10])
Immunoglobulins | Blood product | Pregnancy | Breast Feeding
Item
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. pregnant or lactating female.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
boolean
C0032992 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
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