ID

44560

Beskrivning

Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00657657

Länk

https://clinicaltrials.gov/show/NCT00657657

Nyckelord

Versioner (2)
  1. 2018-04-09 2018-04-09 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00657657

Engelsk

Eligibility Hepatitis B NCT00657657

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine (engerix™-b), in the 103860/272 primary study approximately 20 years earlier.
Beskrivning

Adult | Vaccination Primary Neonatal Complete | Hepatitis B Vaccine | Engerix-B

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C2939425
UMLS CUI [2,4]
C0205197
UMLS CUI [3]
C2240392
UMLS CUI [4]
C0116078
documented level of anti-hbs antibody concentrations < 100 milli-international units per milliliter (miu/ml) at the previous long-term time-point for which serological results are available for that subject.
Beskrivning

Anti-HBs antibody Level mIU/mL

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201478
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0439457
written informed consent obtained from the subject.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
healthy subjects as established by medical history and clinical examination before entering into the study.
Beskrivning

Healthy Volunteers Medical History | Healthy Volunteers Clinical examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C1456356
if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis b challenge dose.
Beskrivning

Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beskrivning

Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C0013231
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2348563
UMLS CUI [5,3]
C0042210
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
Beskrivning

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis b vaccine challenge dose and ending 30 days after.
Beskrivning

Vaccines Planned | Exception Study Protocol Vaccines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0042210
subjects who received a booster dose of hepatitis b vaccine outside the context of this study between the long-term time-point at the documented level of anti-hbs antibody concentrations and the current challenge dose study visit.
Beskrivning

Booster hepatitis B vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0419731
concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Beskrivning

Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Non-Prescription Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0013231
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beskrivning

Hypersensitivity Exacerbated | Allergic Reaction Exacerbated | Etiology Vaccine Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C1705248
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Beskrivning

Immunosuppression | Immunodeficiency | Immunosuppression Suspected | Immunodeficiency Suspected | HIV Infection | HIV Infection Suspected

Datatyp

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
UMLS CUI [6,1]
C0019693
UMLS CUI [6,2]
C0750491
acute disease at the time of enrolment.
Beskrivning

Acute Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0001314
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Beskrivning

Pulmonary function Abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Pulmonary function Abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Screening test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0232090
UMLS CUI [3]
C0086565
UMLS CUI [4]
C0151746
UMLS CUI [5,1]
C0231921
UMLS CUI [5,2]
C0205161
UMLS CUI [5,3]
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 [10,1]
C0022877
UMLS CUI [10,2]
C0871311
administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis b vaccine challenge dose or planned administration during the study period.
Beskrivning

Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1301732
pregnant or lactating female.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions.
Beskrivning

Gender | Pregnancy, Planned | Contraceptive methods Discontinue Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1301732
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Similar models

Eligibility Hepatitis B NCT00657657

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance
Item
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Adult | Vaccination Primary Neonatal Complete | Hepatitis B Vaccine | Engerix-B
Item
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine (engerix™-b), in the 103860/272 primary study approximately 20 years earlier.
boolean
C0001675 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2939425 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C2240392 (UMLS CUI [3])
C0116078 (UMLS CUI [4])
Anti-HBs antibody Level mIU/mL
Item
documented level of anti-hbs antibody concentrations < 100 milli-international units per milliliter (miu/ml) at the previous long-term time-point for which serological results are available for that subject.
boolean
C0201478 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0439457 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers Medical History | Healthy Volunteers Clinical examination
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis b challenge dose.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines
Item
use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C0013231 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2348563 (UMLS CUI [5,2])
C0042210 (UMLS CUI [5,3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Vaccines Planned | Exception Study Protocol Vaccines
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis b vaccine challenge dose and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Booster hepatitis B vaccination
Item
subjects who received a booster dose of hepatitis b vaccine outside the context of this study between the long-term time-point at the documented level of anti-hbs antibody concentrations and the current challenge dose study visit.
boolean
C0419731 (UMLS CUI [1])
Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Non-Prescription Drugs
Item
concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
boolean
C2348568 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0013231 (UMLS CUI [3,2])
Hypersensitivity Exacerbated | Allergic Reaction Exacerbated | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Immunosuppression | Immunodeficiency | Immunosuppression Suspected | Immunodeficiency Suspected | HIV Infection | HIV Infection Suspected
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])
C0019693 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Pulmonary function Abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Pulmonary function Abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Screening test
Item
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0231921 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0232090 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0151746 (UMLS CUI [4])
C0231921 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
C0205191 (UMLS CUI [5,3])
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])
C0022877 (UMLS CUI [10,1])
C0871311 (UMLS CUI [10,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis b vaccine challenge dose or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender | Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0079399 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
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