Gender and Age
Item
A male or female between and including, 11 and 15 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed consent
Item
Written informed consent obtained from the subject and subject’s parent/guardian.
boolean
C0021430 (UMLS CUI [1])
Health problems
Item
Free of obvious health problems as established by medical history and clinical examination before entering the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Contraception or Pregnancy
Item
If the subject is female and 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.
boolean
C0032961 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
HBs antigen, anti-HBc antibodies and anti-HBs antibodies
Item
Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies.
boolean
C0201478 (UMLS CUI [1,1])
C0201480 (UMLS CUI [1,2])
C0201477 (UMLS CUI [1,3])
Use of other study drugs
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned to use during the study period.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Other vaccines
Item
Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Previous Hep B vaccination
Item
Previous vaccination against hepatitis B.
boolean
C0474232 (UMLS CUI [1])
Hep B Exposure
Item
Known exposure to hepatitis B within the previous 6 weeks.
boolean
C0019163 (UMLS CUI [1])
History of hepatitis B infection
Item
History of hepatitis B infection.
boolean
C0019163 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
Allergies, Hypersensitivity to vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Acute disease
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])
Hepatic disease
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0023895 (UMLS CUI [1])
Immunoglobulins and blood products
Item
Administration of immunoglobulins and 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])
C0456388 (UMLS CUI [2])
Pregnancy or breast feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Chronic drug therapy
Item
Any chronic drug therapy to be continued during the study period.
boolean
C0013216 (UMLS CUI [1])
Comorbidities
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C4061114 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Congenital defects or serious chronic illness
Item
Major congenital defects or serious chronic illness.
boolean
C0220810 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Alcohol or drug abuse
Item
History of chronic alcohol consumption and/or intravenous drug abuse.
boolean
C0038586 (UMLS CUI [1])
Planned pregnancy
Item
Female planning to become pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Use of other study drug
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Intravenous drug abuse
Item
Intravenous drug abuse.
boolean
C0086181 (UMLS CUI [1])
Pregnancy planned
Item
Female deciding to become pregnant.
boolean
C0032961 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Other vaccines
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])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins and/or blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Hepatic disease
Item
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0023895 (UMLS CUI [1])
Anaphylactic reaction to vaccination
Item
Anaphylactic reaction following the administration of vaccine.
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute disease
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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 99.5°F (37.5°C) / axillary temperature < 99.5°F (37.5°C).
boolean
C0001314 (UMLS CUI [1])