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 | Hepatitis B Vaccines
Item
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine in 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])
C2240392 (UMLS CUI [3])
Hepatitis B surface antibody measurement
Item
documented level of anti-hbs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
boolean
C0201478 (UMLS CUI [1])
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])
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])
Vaccine | Exception Study Protocol Vaccine
Item
administration of a vaccine not foreseen by the study protocol during the study period.
boolean
C0042210 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Substance Use Disorders
Item
drug and/or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])