Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from the parent/legal guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Free of Health problem | Medical History | Clinical Examination
Item
free of obvious health problems as established by medical history and/or clinical examination before entering the study.
boolean
C0332296 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Body Weight | Age
Item
at least 8 kg of body weight at age of 12 months.
boolean
C0005910 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Enrollment Clinical Trial Original | Randomization Clinical Trial Original | Vaccines Dose Quantity | Vaccines Investigational Hepatitis A
Item
subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines.
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205313 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205313 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0042210 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0019159 (UMLS CUI [4,3])
Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Children | Diphtheria-Tetanus-acellular Pertussis Vaccines Absent | Oral Polio Vaccine Absent
Item
children not having received 3 documented doses of dtpahib and polio vaccines during infancy
boolean
C0008059 (UMLS CUI [1])
C0535644 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032375 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Children | Measles-Mumps-Rubella Vaccine Dose
Item
children having received a documented dose of mmr during infancy
boolean
C0008059 (UMLS CUI [1])
C0065828 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES | Investigational New Drugs Planned | Non-Prescription Drugs Planned | INVESTIGATIONAL VACCINES Planned
Item
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1875384 (UMLS CUI [3])
C0013230 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0013231 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C1875384 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
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 first vaccine dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE | Inhaled steroids allowed | Topical steroids allowed
Item
administration of systemic corticosteroids (inhaled and topical steroids are allowed).
boolean
C3653708 (UMLS CUI [1])
C2065041 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C2064827 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Vaccine Except Study Protocol
Item
administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
boolean
C0042210 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Vaccination Previous Hepatitis A
Item
previous vaccination against hepatitis a.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0019159 (UMLS CUI [1,3])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
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])
C0019693 (UMLS CUI [5])
Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | 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])
C4086268 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Congenital defects Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Vaccine Containing Hepatitis A Antigen
Item
children who had received a hepatitis a antigen containing vaccine since the last visit
boolean
C0042210 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0062523 (UMLS CUI [1,3])