ID

13216

Description

Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B; ODM derived from: https://clinicaltrials.gov/show/NCT00698087

Lien

https://clinicaltrials.gov/show/NCT00698087

Mots-clés

  1. 24/01/2016 24/01/2016 -
Téléchargé le

24 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00698087

Eligibility Hepatitis B NCT00698087

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
between 18 and 40 years old.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent will have been obtained from the subjects.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
good physical condition as established by physical examination and history taking at the time of entry.
Description

physical condition

Type de données

boolean

Alias
UMLS CUI [1]
C1142435
female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry
Description

pregnancy, contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation.
Description

pregnancy or lactation

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive titres for anti hepatitis b antibodies
Description

hepatitis b antibodies

Type de données

boolean

Alias
UMLS CUI [1]
C0019164
UMLS CUI [2]
C0019163
any vaccination against hepatitis b in the past.
Description

Hepatitis B vaccination

Type de données

boolean

Alias
UMLS CUI [1]
C0474232
any previous administration of mpl.
Description

monophosphoryl lipid A

Type de données

boolean

Alias
UMLS CUI [1]
C0066776
elevated serum liver enzymes.
Description

serum liver enzymes

Type de données

boolean

Alias
UMLS CUI [1]
C1287351
history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Description

hematologic, hepatic, renal, cardiac or respiratory disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
axillary temperature > 37.5°c at the time of injection.
Description

axillary temperature

Type de données

boolean

Alias
UMLS CUI [1]
C1531924
UMLS CUI [2]
C0039476
any acute disease at the moment of entry.
Description

acute disease at the moment of entry

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
chronic alcohol consumption.
Description

alcoholism

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
any treatment with immunosuppressive or immunostimulant therapy.
Description

immunosuppression or immunostimulant therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0001551
any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
Description

chronic drug treatment precluding inclusion

Type de données

boolean

Alias
UMLS CUI [1]
C0013216
history of allergic disease likely to be stimulated by any component of the vaccine.
Description

allergic disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
simultaneous administration of any other vaccine(s).
Description

Vaccine administration

Type de données

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C0042196
administration of any immunoglobulin during the study period.
Description

immunoglobulin administration

Type de données

boolean

Alias
UMLS CUI [1]
C0021027
simultaneous participation in any other clinical trial
Description

study participation status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hepatitis B NCT00698087

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between 18 and 40 years old.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
written informed consent will have been obtained from the subjects.
boolean
C0021430 (UMLS CUI [1])
physical condition
Item
good physical condition as established by physical examination and history taking at the time of entry.
boolean
C1142435 (UMLS CUI [1])
pregnancy, contraceptive methods
Item
female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hepatitis b antibodies
Item
positive titres for anti hepatitis b antibodies
boolean
C0019164 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Hepatitis B vaccination
Item
any vaccination against hepatitis b in the past.
boolean
C0474232 (UMLS CUI [1])
monophosphoryl lipid A
Item
any previous administration of mpl.
boolean
C0066776 (UMLS CUI [1])
serum liver enzymes
Item
elevated serum liver enzymes.
boolean
C1287351 (UMLS CUI [1])
hematologic, hepatic, renal, cardiac or respiratory disease
Item
history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
boolean
C0009488 (UMLS CUI [1])
axillary temperature
Item
axillary temperature > 37.5°c at the time of injection.
boolean
C1531924 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
acute disease at the moment of entry
Item
any acute disease at the moment of entry.
boolean
C0009488 (UMLS CUI [1])
alcoholism
Item
chronic alcohol consumption.
boolean
C0038586 (UMLS CUI [1,1])
immunosuppression or immunostimulant therapy
Item
any treatment with immunosuppressive or immunostimulant therapy.
boolean
C0021081 (UMLS CUI [1])
C0001551 (UMLS CUI [2])
chronic drug treatment precluding inclusion
Item
any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
boolean
C0013216 (UMLS CUI [1])
allergic disease
Item
history of allergic disease likely to be stimulated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Vaccine administration
Item
simultaneous administration of any other vaccine(s).
boolean
C0042210 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
immunoglobulin administration
Item
administration of any immunoglobulin during the study period.
boolean
C0021027 (UMLS CUI [1])
study participation status
Item
simultaneous participation in any other clinical trial
boolean
C2348568 (UMLS CUI [1])

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