ID

14147

Beschreibung

Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y; ODM derived from: https://clinicaltrials.gov/show/NCT00696917

Link

https://clinicaltrials.gov/show/NCT00696917

Stichworte

Versionen (1)
  1. 31.03.16 31.03.16 -
Hochgeladen am

31. März 2016

DOI

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Lizenz

Creative Commons BY-NC-ND 3.0
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Eligibility Hepatitis B NCT00696917

Englisch

Eligibility Hepatitis B NCT00696917

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female aged ≥ 15 years at the time of the first vaccination. in centre 103 (germany) and centre 1 (netherlands), only subjects ≥ 18 years will be enrolled.
Beschreibung

Gender, age at the first vaccination and age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0419726
UMLS CUI [3]
C0001779
free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

Medical history and clinical examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C1456356
written informed consent obtained from the subject and/or from the parent or guardian of the subject.
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
if the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria
Beschreibung

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.
Beschreibung

Experimental drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
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.
Beschreibung

Planned vaccination beyond study protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0205101
UMLS CUI [1,4]
C2348563
previous vaccination against hepatitis b.
Beschreibung

Hepatitis B vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0474232
history of non-response to previous hepatitis b vaccination.
Beschreibung

Response to hepatitis B vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C1548130
known exposure to hepatitis b virus within 6 weeks.
Beschreibung

HBV exposure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0332157
history of hepatitis b infection.
Beschreibung

Hepatitis b infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
confirmed human immunodeficiency virus (hiv) infection.
Beschreibung

HIV infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
a family history of congenital or hereditary immunodeficiency.
Beschreibung

Congenital or hereditary immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0853602
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

Hypersensitivity to vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
acute disease at the time of enrollment.
Beschreibung

Acute disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
hepatomegaly, right upper quadrant abdominal pain or tenderness.
Beschreibung

Hepatomegaly, right upper quadrant abdominal pain or tenderness

Datentyp

boolean

Alias
UMLS CUI [1]
C0019209
UMLS CUI [2]
C0235299
UMLS CUI [3]
C0238571
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.
Beschreibung

Pharmacotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021022
UMLS CUI [2]
C0852255
UMLS CUI [3]
C0042196
pregnant or lactating female
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Hepatitis B NCT00696917

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender, age at the first vaccination and age
Item
a male or female aged ≥ 15 years at the time of the first vaccination. in centre 103 (germany) and centre 1 (netherlands), only subjects ≥ 18 years will be enrolled.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0419726 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Medical history and clinical examination
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1])
C1456356 (UMLS CUI [2])
Written informed consent
Item
written informed consent obtained from the subject and/or from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
Gynaecological status
Item
if the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Experimental drug
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
C0304229 (UMLS CUI [1])
Planned vaccination beyond 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 [1,1])
C1301732 (UMLS CUI [1,2])
C0205101 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Hepatitis B vaccination
Item
previous vaccination against hepatitis b.
boolean
C0474232 (UMLS CUI [1])
Response to hepatitis B vaccination
Item
history of non-response to previous hepatitis b vaccination.
boolean
C0474232 (UMLS CUI [1,1])
C1548130 (UMLS CUI [1,2])
HBV exposure
Item
known exposure to hepatitis b virus within 6 weeks.
boolean
C0019169 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Hepatitis b infection
Item
history of hepatitis b infection.
boolean
C0019163 (UMLS CUI [1])
HIV infection
Item
confirmed human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Congenital or hereditary immunodeficiency
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1])
Hypersensitivity to vaccine
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Acute disease
Item
acute disease at the time of enrollment.
boolean
C0001314 (UMLS CUI [1])
Hepatomegaly, right upper quadrant abdominal pain or tenderness
Item
hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1])
C0235299 (UMLS CUI [2])
C0238571 (UMLS CUI [3])
Pharmacotherapy
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
C0021022 (UMLS CUI [1])
C0852255 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Gynaecological status
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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