ID

44119

Beschreibung

A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines; ODM derived from: https://clinicaltrials.gov/show/NCT02032160

Link

https://clinicaltrials.gov/show/NCT02032160

Stichworte

Versionen (2)
  1. 07.04.19 07.04.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT02032160

Englisch

Eligibility Hepatitis B NCT02032160

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy male subjects aged 18-55 years inclusive
Beschreibung

Healthy Volunteers | Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
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.
Beschreibung

Healthy Volunteers | Physical Examination | Medical History | Blood test result | Vital signs | Disease Absent | Interference Endpoints Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0849535
UMLS CUI [5]
C0518766
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0521102
UMLS CUI [7,2]
C2349179
UMLS CUI [7,3]
C0332197
3. the subject is able to read and understand the informed consent form (icf), and understand study procedures.
Beschreibung

Able to read Informed Consent | Comprehension Informed Consent | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0021430
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
4. the subject has signed the icf.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
5. the subject has not previously received a vaccine for hepatitis b or contracted hepatitis b infection.
Beschreibung

Vaccine Absent Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019163
6. the subject is seronegative to hepatitis b as confirmed at screening by assessments of sab, sag, and cab.
Beschreibung

Serology negative Hepatitis B | Hepatitis B surface antibody measurement | Hepatitis B surface antigen measurement | Hepatitis B core antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019163
UMLS CUI [2]
C0201478
UMLS CUI [3]
C0201477
UMLS CUI [4]
C0201479
7. seronegative for hiv 1 & 2 antibodies and hepatitis c antibodies at screening.
Beschreibung

Serology negative HIV-1 antibody | Serology negative Antibody hiv-2 | Serology negative Hepatitis C Antibodies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0369497
UMLS CUI [2,1]
C0919674
UMLS CUI [2,2]
C3469372
UMLS CUI [3,1]
C0919674
UMLS CUI [3,2]
C0166049
8. available for follow-up for the duration of the study.
Beschreibung

Patient Available Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
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.
Beschreibung

Avoidance Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0005794
10. visa long enough allowing them to complete the study (if applicable).
Beschreibung

Visa allowing Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1549756
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C2732579
11. the subject has venous access sufficient to allow blood sampling as per the protocol.
Beschreibung

Venous access patent allowing Venous blood sampling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3164222
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0190979
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0037494
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C3256748
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C3256930
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0051519
UMLS CUI [6]
C3846158
UMLS CUI [7]
C0570590
UMLS CUI [8]
C3846158
UMLS CUI [9]
C0571556
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1444657
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).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0200635
UMLS CUI [3,1]
C0020987
UMLS CUI [3,2]
C0332268
UMLS CUI [4]
C0023418
UMLS CUI [5]
C0024299
UMLS CUI [6]
C0018939
UMLS CUI [7]
C0021079
UMLS CUI [8,1]
C0001617
UMLS CUI [8,2]
C1527415
UMLS CUI [9,1]
C0001617
UMLS CUI [9,2]
C0205535
UMLS CUI [10]
C0304604
UMLS CUI [11,1]
C0001617
UMLS CUI [11,2]
C1518896
3. use of any immune suppressing or immunomodulating drugs within 6 months of visit 1 (screening).
Beschreibung

Immunosuppressive Agents | Biological Response Modifiers

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0005525
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.
Beschreibung

Non-Steroidal Anti-Inflammatory Agents Interfere with Immune response | Non-Steroidal Anti-Inflammatory Agents Topical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0020964
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1522168
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.
Beschreibung

Vaccines

Datentyp

boolean

Alias
UMLS CUI [1]
C0042210
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.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Pharmaceutical Preparations | Investigational Medical Device | Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0013227
UMLS CUI [4]
C2346570
UMLS CUI [5]
C0025080
7. any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
Beschreibung

Condition compromises Protocol Compliance | Condition compromises Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2732579
8. receipt of blood products or immunoglobin, or blood donation, within 3 months of screening.
Beschreibung

Blood product Received | Immunoglobulin Therapy | Blood Donation Received

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C1514756
UMLS CUI [2]
C0021022
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1514756
9. unable to read and speak english to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Beschreibung

Lacking Able to read English Language | Lacking Able to speak fluently English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564241
UMLS CUI [2,3]
C0376245
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Ähnliche Modelle

Eligibility Hepatitis B NCT02032160

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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