Inclusion criteria All Fulfill
Item
to receive the first study vaccination, participants should meet all inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent
Item
participants provide written informed consent for the trial. the participant may also provide consent for future biomedical research. however, the participant may participate in the main trial without participating in future biomedical research.
boolean
C0021430 (UMLS CUI [1])
Japanese | Age
Item
participant is japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
boolean
C1556094 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
General health good | Primary disease chronic;documented | Patient's condition stable
Item
participant is determined to be in general good health based on the medical history taken on day 1 prior to receiving the first injection of the vaccine. any underlying chronic illness must be documented to be in stable condition.
boolean
C1277245 (UMLS CUI [1])
C0277554 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1301725 (UMLS CUI [2,3])
C1282982 (UMLS CUI [3])
Gender Urine pregnancy test negative
Item
for females, a negative urine pregnancy test just prior to vaccination on day 1.
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Exclusion Criteria Fulfill
Item
to receive the first study vaccination, participants should not have any exclusion criteria. for items with an asterisk (*), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hepatitis B Previous
Item
participant has a history of previous hepatitis b infection.
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hepatitis B vaccination
Item
participant has a history of vaccination with any hepatitis b vaccine.
boolean
C0474232 (UMLS CUI [1])
Disorder characterized by fever | Oral temperature
Item
*participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥
boolean
C0743841 (UMLS CUI [1])
C1532216 (UMLS CUI [2])
ID.10
Item
37.8°c).
boolean
Other Coding | Hypersensitivity Component Heptavax | Hypersensitivity Suspected Component Heptavax | Latex allergy | Latex allergy Suspected | Allergy to aluminum | Allergy to yeast
Item
participant has a known or suspected hypersensitivity to any component of heptavax™-ii vaccine and latex (e.g., aluminum, yeast).
boolean
C3846158 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0121517 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0121517 (UMLS CUI [3,4])
C0577628 (UMLS CUI [4])
C0577628 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C1275435 (UMLS CUI [6])
C3875439 (UMLS CUI [7])
Hepatitis B immune globulin | Immune serum globulin given | Blood product | Blood product Required
Item
participant has a recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product, or is expected to require such blood-derived products during the study.
boolean
C0062525 (UMLS CUI [1])
C0486994 (UMLS CUI [2])
C0456388 (UMLS CUI [3])
C0456388 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Vaccines, Inactivated
Item
*participant has received licensed inactivated vaccines within 14 days prior or licensed live vaccines within 28 days prior to first injection with the study vaccine.
boolean
C0042212 (UMLS CUI [1])
Investigational New Drugs | INVESTIGATIONAL VACCINES
Item
participant has received investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
boolean
C0013230 (UMLS CUI [1])
C1875384 (UMLS CUI [2])
Therapeutic immunosuppression | Adrenal Cortex Hormones Dose Systemic | Prednisone Dose U/day | Exception Topical Steroid Therapy | Exception Inhaled steroid therapy
Item
use of immunosuppressive therapy. participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to enrollment until 6 weeks post vaccination, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) per day for >2 weeks (except for use of topical or inhalation steroid therapy).
boolean
C0021079 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0032952 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3897353 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C4039912 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods | Female Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant Hormonal
Item
pregnant women, nursing mothers, and women planning to become pregnant within the study period. women of childbearing age should employ an acceptable method of contraception during the study (e.g., condom, diaphragm, oral contraceptive, intrauterine device (iud), or hormonal implants are considered acceptable).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0221829 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C1657106 (UMLS CUI [9,1])
C0458083 (UMLS CUI [9,2])
Condition Interferes with Evaluation Research data
Item
participant has any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
Blood Coagulation Disorders | Intramuscular injection Contraindicated
Item
participant has a coagulation disorder contraindicating intramuscular injection.
boolean
C0005779 (UMLS CUI [1])
C0021492 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
Immunocompromised patient | HIV Seropositivity | Leukemia | Lymphoma | Cancer Other | Disease Other
Item
participant has immunocompromised condition (such as human immunodeficiency virus (hiv) positive, leukemia, lymphoma, other cancers or disorders).
boolean
C0085393 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0023418 (UMLS CUI [3])
C0024299 (UMLS CUI [4])
C1707251 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])