Informações:
Falhas:
ID
13216
Descrição
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
Link
https://clinicaltrials.gov/show/NCT00698087
Palavras-chave
Versões (1)
- 24/01/2016 24/01/2016 -
Transferido a
24 de janeiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00698087
Eligibility Hepatitis B NCT00698087
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00698087
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0700589 (UMLS CUI [2])
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
hepatitis b antibodies
Item
positive titres for anti hepatitis b antibodies
boolean
C0019164 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
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])
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])
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])
C1521826 (UMLS CUI [1,2])
Vaccine administration
Item
simultaneous administration of any other vaccine(s).
boolean
C0042210 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
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])