Protocol Compliance Parent | Protocol Compliance Patient Representative
Item
subjects who the investigator believes that their parent(s)/legally acceptable representative(s) 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])
C0030701 (UMLS CUI [2,2])
Age
Item
a male or female 7 to 8 years of age at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
Vaccination Previous | Infanrix hexa Dose Quantity
Item
subjects with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ as part of routine vaccination in germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3661302 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent Parent | Informed Consent Patient Representative
Item
written informed consent obtained from the parents/legally acceptable representative(s) of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Informed Consent
Item
in addition to the informed consent that will be signed by the parent(s)/legally acceptable representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
boolean
C0021430 (UMLS CUI [1])
Healthy Subjects Medical History | Healthy Subjects 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])
Child in care
Item
child in care
boolean
C0728735 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription | Exception Study Protocol Vaccine
Item
use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial | Exposure to Investigational New Drugs | Exposure to Pharmacologic Substance
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])
C0008976 (UMLS CUI [2])
C0332157 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
Booster hepatitis B vaccination Previous
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 [1,1])
C0205156 (UMLS CUI [1,2])
History of hepatitis B | Hepatitis B Intercurrent
Item
history of or intercurrent hepatitis b disease.
boolean
C1997078 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0277557 (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])
Administration of vaccine Planned | Administration of vaccine | Exception Study Protocol Vaccine
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis b vaccine challenge dose.
boolean
C2368628 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Immunoglobulins | Administration of blood product
Item
administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0150150 (UMLS CUI [2])
Immunosuppressive Agents chronic | Immunomodulators chronic
Item
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of hbv vaccine.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Allergic Reaction Exacerbated | Hypersensitivity Exacerbated | Etiology Component Hepatitis B Vaccine | Hypersensitivity Post Hepatitis B Vaccine Immunization
Item
history of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis b vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis b component.
boolean
C1527304 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C2240392 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C2240392 (UMLS CUI [4,3])
C0020971 (UMLS CUI [4,4])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
boolean
C4048329 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Acute illness | Fever
Item
acute disease and/or fever at the time of enrolment.
boolean
C4061114 (UMLS CUI [1])
C0015967 (UMLS CUI [2])