Gender, Age
Item
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Health Status
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
Childbearing Potential, Pregnancy test negative
Item
If the subject is female, she must be of non-childbearing, i.e., either surgically sterilised or one year post- menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
text
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Pharmaceutical Preparations, Vaccines
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration of vaccine, Planned
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C2368628 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Hepatitis B vaccination, Previous
Item
Previous vaccination against hepatitis B.
boolean
C0474232 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hepatitis B vaccination, Previous, Absent response to treatment
Item
History of non-response to previous hepatitis B vaccination.
boolean
C0474232 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
Hepatitis B, Exposure to
Item
Known exposure to hepatitis B within the previous 6 weeks.
boolean
C0019163 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Hepatitis B, Medical History
Item
History of hepatitis B infection.
boolean
C0019163 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Immunosuppression, Immunologic Deficiency Syndromes, HIV
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
Immunodeficiency congenital, Immunologic Deficiency Syndromes, Hereditary, Family history
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Hypersensitivity, Medical History
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Acute Disease, Enrollment
Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, at the investigator's discretion)
boolean
C0001314 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1,1])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Pregnancy, Breast Feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Hepatitis B positive
Item
Subjects being found to be positive for any hepatitis B marker (anti-HBs, anti-HBc, HBsAg) tested at pre-vaccination.
boolean
C0856706 (UMLS CUI [1])
Pharmaceutical Preparations, Vaccines
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccines, Administration procedure
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products during the study
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Pregnancy, Planned
Item
Female deciding to become pregnant.
boolean
C0032992 (UMLS CUI [1])
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1,1])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
Anaphylaxis, Vaccination
Item
Anaphylactic reaction following the administration of vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute Disease, Vaccination
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness (at the investigator's discretion)
boolean
C0001314 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])