Informações:
Falhas:
ID
13597
Descrição
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B; ODM derived from: https://clinicaltrials.gov/show/NCT00697840
Link
https://clinicaltrials.gov/show/NCT00697840
Palavras-chave
Versões (1)
- 18/02/2016 18/02/2016 -
Transferido a
18 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00697840
Eligibility Hepatitis B NCT00697840
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00697840
- 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])
written informed consent
Item
written informed consent will have been obtained from the subjects.
boolean
C0021430 (UMLS CUI [1])
good 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
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])
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Hepatitis B surface antibody
Item
positive titres for anti hbs antibody.
boolean
C0149708 (UMLS CUI [1])
Hepatitis B vaccination
Item
any vaccination against hepatitis b in the past.
boolean
C0474232 (UMLS CUI [1])
mpl administration
Item
any previous administration of mpl.
boolean
C0066776 (UMLS CUI [1])
elevated 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])
any acute disease
Item
any acute disease at the moment of entry.
boolean
C0009488 (UMLS CUI [1])
chronic alcohol consumption
Item
chronic alcohol consumption.
boolean
C0038586 (UMLS CUI [1])
immunosuppressive or immunostimulant
Item
any treatment with immunosuppressive or immunostimulant therapy.
boolean
C0021079 (UMLS CUI [1])
C0001551 (UMLS CUI [2])
C0001551 (UMLS CUI [2])
drug treatment precluding inclustion into study
Item
any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
boolean
C0013216 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C1321605 (UMLS CUI [2])
hypersensitivitiy to vaccine
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])
simultaneous administration of any other vaccines
Item
simultaneous administration of any other vaccine(s).
boolean
C1321605 (UMLS CUI [1])
administration of any immunoglobulin
Item
administration of any immunoglobulin during the study period.
boolean
C1321605 (UMLS CUI [1])
study participation status
Item
simultaneous participation in any other clinical trial.
boolean
C2348568 (UMLS CUI [1])