Protocol Compliance
Item
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Adult | Vaccination Primary Neonatal Complete | Hepatitis B Vaccine | Engerix-B
Item
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine (engerix™-b), in the 103860/272 primary study approximately 20 years earlier.
boolean
C0001675 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2939425 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C2240392 (UMLS CUI [3])
C0116078 (UMLS CUI [4])
Anti-HBs antibody Level mIU/mL
Item
documented level of anti-hbs antibody concentrations < 100 milli-international units per milliliter (miu/ml) at the previous long-term time-point for which serological results are available for that subject.
boolean
C0201478 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0439457 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers Medical History | Healthy Volunteers Clinical examination
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis b challenge dose.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines
Item
use of any investigational or non-registered product (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
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C0013231 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2348563 (UMLS CUI [5,2])
C0042210 (UMLS CUI [5,3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Vaccines Planned | Exception Study Protocol Vaccines
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis b vaccine challenge dose and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Booster hepatitis B vaccination
Item
subjects who received a booster dose of hepatitis b vaccine outside the context of this study between the long-term time-point at the documented level of anti-hbs antibody concentrations and the current challenge dose study visit.
boolean
C0419731 (UMLS CUI [1])
Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Non-Prescription Drugs
Item
concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
boolean
C2348568 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0013231 (UMLS CUI [3,2])
Hypersensitivity Exacerbated | Allergic Reaction Exacerbated | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Immunosuppression | Immunodeficiency | Immunosuppression Suspected | Immunodeficiency Suspected | HIV Infection | HIV Infection Suspected
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0019693 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Pulmonary function Abnormal | Abnormal cardiovascular function | Liver Dysfunction | Abnormal renal function | Pulmonary function Abnormal chronic | Abnormal cardiovascular function chronic | Liver Dysfunction chronic | Abnormal renal function chronic | Physical Examination | Laboratory Screening test
Item
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0231921 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0232090 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0151746 (UMLS CUI [4])
C0231921 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
C0205191 (UMLS CUI [5,3])
C0232090 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C0086565 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0151746 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0031809 (UMLS CUI [9])
C0022877 (UMLS CUI [10,1])
C0871311 (UMLS CUI [10,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis b vaccine challenge dose or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender | Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0079399 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])