ID

13192

Descripción

Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00697242

Link

https://clinicaltrials.gov/show/NCT00697242

Palabras clave

  1. 23/1/16 23/1/16 -
Subido en

23 de enero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00697242

Eligibility Hepatitis B NCT00697242

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male or female subjects between 50 and 70 years old.
Descripción

Age, Gender, Health status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0424576
written informed consent will have been obtained from the subjects.
Descripción

written informed consent

Tipo de datos

boolean

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

physical condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424576
UMLS CUI [2]
C1142435
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive titres for anti hepatitis antibodies
Descripción

anti hepatitis antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019161
UMLS CUI [2]
C0019164
any vaccination against hepatitis b in the past.
Descripción

hepatitis b vaccination

Tipo de datos

boolean

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

administration of mpl

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0066776
elevated serum liver enzymes at two subsequent determinations 14 days apart.
Descripción

serum liver enzymes

Tipo de datos

boolean

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

Comorbidity

Tipo de datos

boolean

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

axillary temperature

Tipo de datos

boolean

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

acute diseases

Tipo de datos

boolean

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

alcoholism

Tipo de datos

boolean

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

immunosuppressive therapy or immunostimulant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0001551
any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
Descripción

chronic drug treatment

Tipo de datos

boolean

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

allergic diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0020517
administration of any other vaccine(s) or any immunoglobulin during the study period.
Descripción

vaccine(s) or any immunoglobulins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C0021027
simultaneous participation in any other clinical trial.
Descripción

participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hepatitis B NCT00697242

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age, Gender, Health status
Item
healthy male or female subjects between 50 and 70 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0424576 (UMLS CUI [3])
written 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
C0424576 (UMLS CUI [1])
C1142435 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
anti hepatitis antibodies
Item
positive titres for anti hepatitis antibodies
boolean
C0019161 (UMLS CUI [1])
C0019164 (UMLS CUI [2])
hepatitis b vaccination
Item
any vaccination against hepatitis b in the past.
boolean
C0474232 (UMLS CUI [1])
administration of mpl
Item
any previous administration of mpl
boolean
C0066776 (UMLS CUI [1])
serum liver enzymes
Item
elevated serum liver enzymes at two subsequent determinations 14 days apart.
boolean
C1287351 (UMLS CUI [1])
Comorbidity
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 diseases
Item
any acute disease at the moment of entry.
boolean
C0009488 (UMLS CUI [1])
alcoholism
Item
chronic alcohol consumption.
boolean
C0038586 (UMLS CUI [1])
immunosuppressive therapy or immunostimulant therapy
Item
any treatment with immunosuppressive or immunostimulant therapy.
boolean
C0021079 (UMLS CUI [1])
C0001551 (UMLS CUI [2])
chronic drug treatment
Item
any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
boolean
C0013216 (UMLS CUI [1])
allergic diseases
Item
history of allergic disease likely to be stimulated by any component of the vaccine.
boolean
C0009488 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
vaccine(s) or any immunoglobulins
Item
administration of any other vaccine(s) or any immunoglobulin during the study period.
boolean
C0042210 (UMLS CUI [1])
C0021027 (UMLS CUI [2])
participation status
Item
simultaneous participation in any other clinical trial.
boolean
C2348568 (UMLS CUI [1])

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