Protocol Compliance parent | Protocol Compliance Guardian
Item
subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Age
Item
a male or female of 4 to 5 years of age at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
Vaccination Evidence of | Infanrix Hexa Dose Quantity
Item
with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ in germany.
boolean
C0042196 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0728745 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent parent | Informed Consent Guardian
Item
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Healthy Volunteers Medical History | Healthy Volunteers Physical 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])
C0031809 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drug Exposure to | Pharmaceutical Preparation Exposure to
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])
C0013230 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
Booster hepatitis B vaccination | Infanrix Hexa Secondary Immunization Dose
Item
evidence of previous hepatitis b booster vaccination since administration of the fourth dose of infanrix hexa™ booster in the second year of life.
boolean
C0419731 (UMLS CUI [1])
C0728745 (UMLS CUI [2,1])
C0020975 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Hepatitis B | Hepatitis B Comorbidity
Item
history of or intercurrent hepatitis b disease.
boolean
C0019163 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
Hepatitis B vaccination at birth
Item
hepatitis b vaccination at birth.
boolean
C0474232 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Vaccine | Vaccine Planned
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
boolean
C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Hepatitis B Virus Vaccine Challenge
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 [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0019169 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C0805586 (UMLS CUI [3,3])