Healthy Volunteers | Gender | Age
Item
1. healthy male subjects aged 18-55 years inclusive
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Healthy Volunteers | Physical Examination | Medical History | Blood test result | Vital signs | Disease Absent | Interference Endpoints Absent
Item
2. the subject is, in the opinion of the investigator, healthy on the basis of a physical examination, medical history, blood results, vital signs, with no active disease process that could interfere with the study endpoints.
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0849535 (UMLS CUI [4])
C0518766 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0521102 (UMLS CUI [7,1])
C2349179 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Able to read Informed Consent | Comprehension Informed Consent | Comprehension Study Protocol
Item
3. the subject is able to read and understand the informed consent form (icf), and understand study procedures.
boolean
C0586740 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Informed Consent
Item
4. the subject has signed the icf.
boolean
C0021430 (UMLS CUI [1])
Vaccine Absent Hepatitis B
Item
5. the subject has not previously received a vaccine for hepatitis b or contracted hepatitis b infection.
boolean
C0042210 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
Serology negative Hepatitis B | Hepatitis B surface antibody measurement | Hepatitis B surface antigen measurement | Hepatitis B core antigen measurement
Item
6. the subject is seronegative to hepatitis b as confirmed at screening by assessments of sab, sag, and cab.
boolean
C0919674 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0201478 (UMLS CUI [2])
C0201477 (UMLS CUI [3])
C0201479 (UMLS CUI [4])
Serology negative HIV-1 antibody | Serology negative Antibody hiv-2 | Serology negative Hepatitis C Antibodies
Item
7. seronegative for hiv 1 & 2 antibodies and hepatitis c antibodies at screening.
boolean
C0919674 (UMLS CUI [1,1])
C0369497 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C3469372 (UMLS CUI [2,2])
C0919674 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
Patient Available Follow-up
Item
8. available for follow-up for the duration of the study.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Avoidance Blood Donation
Item
9. agree to abstain from donating blood during and for three months after the end of their participation in the study, or longer if necessary.
boolean
C0870186 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
Visa allowing Completion of clinical trial
Item
10. visa long enough allowing them to complete the study (if applicable).
boolean
C1549756 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Venous access patent allowing Venous blood sampling
Item
11. the subject has venous access sufficient to allow blood sampling as per the protocol.
boolean
C3164222 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0190979 (UMLS CUI [1,3])
Hypersensitivity Vaccine Component | Hypersensitivity Sodium Chloride | Hypersensitivity Disodium hydrogen phosphate dehydrate | Hypersensitivity Sodium dihydrogen phosphate dihydrate | Hypersensitivity Aluminum phosphate | Other Coding | Aluminum hydroxide allergy | Other Coding | Hepatitis B vaccine allergy | Hypersensitivity Study Subject Participation Status Contraindicated
Item
1. known hypersensitivity to any component of the vaccines (excipients: sodium chloride, disodium phosphate dehydrate, sodium dihydrogen phosphate; adjuvants: aluminium phosphate, as04c, aluminium hydroxide; hepatitis b antigen produced in yeast cells) or subjects who have exhibited hypersensitivity to any other hepatitis b vaccine, or a history of any allergy that in the opinion of the investigator would contraindicate subject participation.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0037494 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C3256748 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C3256930 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0051519 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
C0570590 (UMLS CUI [7])
C3846158 (UMLS CUI [8])
C0571556 (UMLS CUI [9])
C0020517 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444657 (UMLS CUI [10,3])
Immunodeficiency | Lymphocyte Count measurement | Immunocompetence Lacking | Leukemia | Lymphoma | Hematological Disease | Therapeutic immunosuppression | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones by Inhalation | Topical corticosteroids | Adrenal Cortex Hormones Parenteral
Item
2. presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral, inhaled, topical or parenteral corticosteroids).
boolean
C0021051 (UMLS CUI [1])
C0200635 (UMLS CUI [2])
C0020987 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0023418 (UMLS CUI [4])
C0024299 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0021079 (UMLS CUI [7])
C0001617 (UMLS CUI [8,1])
C1527415 (UMLS CUI [8,2])
C0001617 (UMLS CUI [9,1])
C0205535 (UMLS CUI [9,2])
C0304604 (UMLS CUI [10])
C0001617 (UMLS CUI [11,1])
C1518896 (UMLS CUI [11,2])
Immunosuppressive Agents | Biological Response Modifiers
Item
3. use of any immune suppressing or immunomodulating drugs within 6 months of visit 1 (screening).
boolean
C0021081 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
Non-Steroidal Anti-Inflammatory Agents Interfere with Immune response | Non-Steroidal Anti-Inflammatory Agents Topical
Item
4. regular use of non-steroidal anti-inflammatory drugs (by any route of administration including topical) within 6 months of visit 1 (screening) considered by the study physician as likely to interfere with immune responses.
boolean
C0003211 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0020964 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
Vaccines
Item
5. receipt of a vaccine within 30 days of visit 2. other vaccines (e.g. for travel) may be administered between visit 13 and 14 only.
boolean
C0042210 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Pharmaceutical Preparations | Investigational Medical Device | Medical Device
Item
6. currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical study within the 3 months preceding visit 1.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013227 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
C0025080 (UMLS CUI [5])
Condition compromises Protocol Compliance | Condition compromises Completion of clinical trial
Item
7. any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Blood product Received | Immunoglobulin Therapy | Blood Donation Received
Item
8. receipt of blood products or immunoglobin, or blood donation, within 3 months of screening.
boolean
C0456388 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0021022 (UMLS CUI [2])
C0005794 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
Lacking Able to read English Language | Lacking Able to speak fluently English Language
Item
9. unable to read and speak english to a fluency level adequate for the full comprehension of procedures required in participation and consent.
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0564241 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])