Healthy adult | Age
Item
a healthy male or female adult aged between 18 and 40 years.
boolean
C0686750 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent obtained from the subject
boolean
C0021430 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines
Item
use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C0013231 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2348563 (UMLS CUI [5,2])
C0042210 (UMLS CUI [5,3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration 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])
Vaccines | Exception Study Protocol Vaccines | Vaccines, Inactivated | Vaccines, Attenuated
Item
administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
boolean
C0042210 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0042212 (UMLS CUI [3])
C0042211 (UMLS CUI [4])
Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Exposure to Pharmaceutical Preparations | Exposure to Medical Device
Item
concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0025080 (UMLS CUI [5,2])
Hepatitis B
Item
history of hepatitis b infection.
boolean
C0019163 (UMLS CUI [1])
Exposure to Hepatitis B Virus
Item
known exposure to hepatitis b virus within 6 months.
boolean
C0332157 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
Immunosuppression Medical History | Immunosuppression Suspected Medical History | Immunodeficiency Medical History | Immunodeficiency Suspected Medical History | Immunosuppression Clinical examination | Immunosuppression Suspected Clinical examination | Immunodeficiency Clinical examination | Immunodeficiency Suspected Clinical examination
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
boolean
C4048329 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0021051 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0262926 (UMLS CUI [4,3])
C4048329 (UMLS CUI [5,1])
C1456356 (UMLS CUI [5,2])
C4048329 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1456356 (UMLS CUI [6,3])
C0021051 (UMLS CUI [7,1])
C1456356 (UMLS CUI [7,2])
C0021051 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C1456356 (UMLS CUI [8,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0032992 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])