ID

12972

Description

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00697853

Lien

https://clinicaltrials.gov/show/NCT00697853

Mots-clés

  1. 08/01/2016 08/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

8 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Eligibility Hepatitis B NCT00697853

Eligibility Hepatitis B NCT00697853

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female between 15 and 50 years of age at the time of the first vaccination.
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
free of obvious health problems as established by medical history and clinical examination before entering into the study.
Description

health status

Type de données

boolean

Alias
UMLS CUI [1]
C0018759
written informed consent obtained from the subject and/or from the parents or guardians of the subject.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
Description

if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

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

medication

Type de données

boolean

Alias
UMLS CUI [1]
C0013227
administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
Description

administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.

Type de données

boolean

Alias
UMLS CUI [1]
C0021081
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
Description

planned administration/ administration of a vaccine not foreseen by the study protocol

Type de données

boolean

Alias
UMLS CUI [1]
C0042196
previous vaccination against hepatitis b.
Description

previous vaccination against hepatitis b

Type de données

boolean

Alias
UMLS CUI [1]
C0042196
history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
Description

history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Description

any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.

Type de données

boolean

Alias
UMLS CUI [1]
C0021051
a family history of congenital or hereditary immunodeficiency.
Description

a family history of congenital or hereditary immunodeficiency.

Type de données

boolean

Alias
UMLS CUI [1]
C0021051
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Type de données

boolean

Alias
UMLS CUI [1]
C0020517
acute disease at the time of enrollment.
Description

acute disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
hepatomegaly, right upper quadrant abdominal pain or tenderness.
Description

hepatomegaly

Type de données

boolean

Alias
UMLS CUI [1]
C0019209
oral temperature of ≥37.5°c (99.5°f).
Description

temperature

Type de données

boolean

Alias
UMLS CUI [1]
C0039476
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
Description

immunoglobulins and/or any blood products

Type de données

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
pregnant or lactating female.
Description

pregnant or lactating female

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
history of chronic alcohol consumption and/or intravenous drug abuse
Description

history of chronic alcohol consumption and/or intravenous drug abuse

Type de données

boolean

Alias
UMLS CUI [1]
C0038586

Similar models

Eligibility Hepatitis B NCT00697853

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
a male or female between 15 and 50 years of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
health status
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
informed consent
Item
written informed consent obtained from the subject and/or from the parents or guardians of the subject.
boolean
C0021430 (UMLS CUI [1])
if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
Item
if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
medication
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
boolean
C0013227 (UMLS CUI [1])
administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
Item
administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
boolean
C0021081 (UMLS CUI [1])
planned administration/ administration of a vaccine not foreseen by the study protocol
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
previous vaccination against hepatitis b
Item
previous vaccination against hepatitis b.
boolean
C0042196 (UMLS CUI [1])
history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
Item
history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
boolean
C0009488 (UMLS CUI [1])
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C0021051 (UMLS CUI [1])
a family history of congenital or hereditary immunodeficiency.
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0021051 (UMLS CUI [1])
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
acute disease
Item
acute disease at the time of enrollment.
boolean
C0009488 (UMLS CUI [1])
hepatomegaly
Item
hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1])
temperature
Item
oral temperature of ≥37.5°c (99.5°f).
boolean
C0039476 (UMLS CUI [1])
immunoglobulins and/or any blood products
Item
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
pregnant or lactating female
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
history of chronic alcohol consumption and/or intravenous drug abuse
Item
history of chronic alcohol consumption and/or intravenous drug abuse
boolean
C0038586 (UMLS CUI [1])

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