Informações:
Falhas:
ID
13192
Descrição
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
Palavras-chave
Versões (1)
- 23/01/2016 23/01/2016 -
Transferido a
23 de janeiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00697242
Eligibility Hepatitis B NCT00697242
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00697242
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C1142435 (UMLS CUI [2])
anti hepatitis antibodies
Item
positive titres for anti hepatitis antibodies
boolean
C0019161 (UMLS CUI [1])
C0019164 (UMLS CUI [2])
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])
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])
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])
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])
C0021027 (UMLS CUI [2])
participation status
Item
simultaneous participation in any other clinical trial.
boolean
C2348568 (UMLS CUI [1])