ID.1
Item
subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
boolean
C1321605 (UMLS CUI [1])
ID.2
Item
a male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
with documented evidence of previous vaccination with three consecutive doses of engerix™-b in germany
boolean
C0720215 (UMLS CUI [1,1])
C0419728 (UMLS CUI [1,2])
ID.4
Item
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1])
ID.5
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C0424576 (UMLS CUI [1])
ID.6
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
C0008976 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
ID.7
Item
evidence of previous hepatitis b booster vaccination since administration of the third dose of engerix™-b vaccine.
boolean
C0419731 (UMLS CUI [1])
ID.8
Item
history of or intercurrent hepatitis b disease.
boolean
C0019163 (UMLS CUI [1])
ID.9
Item
hepatitis b vaccination at birth.
boolean
C0474232 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
ID.10
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before hbv vaccine challenge and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
ID.11
Item
administration of immunoglobulins and/or any blood products within the three months preceding hbv vaccine challenge or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
ID.12
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hbv vaccine challenge.
boolean
C0021081 (UMLS CUI [1])
ID.13
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
boolean
C0021051 (UMLS CUI [1])