ID

40884

Beschrijving

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062); ODM derived from: https://clinicaltrials.gov/show/NCT01463683

Link

https://clinicaltrials.gov/show/NCT01463683

Trefwoorden

Versies (2)
  1. 30-05-20 30-05-20 -
  2. 31-05-20 31-05-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

31 mei 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01463683

Engels

Eligibility Hepatitis B NCT01463683

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
to receive the first study vaccination, participants should meet all inclusion criteria.
Beschrijving

Inclusion criteria All Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
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.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
participant is japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
Beschrijving

Japanese | Age

Datatype

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0001779
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.
Beschrijving

General health good | Primary disease chronic;documented | Patient's condition stable

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0277554
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C1301725
UMLS CUI [3]
C1282982
for females, a negative urine pregnancy test just prior to vaccination on day 1.
Beschrijving

Gender Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beschrijving

Exclusion Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
participant has a history of previous hepatitis b infection.
Beschrijving

Hepatitis B Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
participant has a history of vaccination with any hepatitis b vaccine.
Beschrijving

Hepatitis B vaccination

Datatype

boolean

Alias
UMLS CUI [1]
C0474232
*participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥
Beschrijving

Disorder characterized by fever | Oral temperature

Datatype

boolean

Alias
UMLS CUI [1]
C0743841
UMLS CUI [2]
C1532216
37.8°c).
Beschrijving

ID.10

Datatype

boolean

participant has a known or suspected hypersensitivity to any component of heptavax™-ii vaccine and latex (e.g., aluminum, yeast).
Beschrijving

Other Coding | Hypersensitivity Component Heptavax | Hypersensitivity Suspected Component Heptavax | Latex allergy | Latex allergy Suspected | Allergy to aluminum | Allergy to yeast

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0121517
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C1705248
UMLS CUI [3,4]
C0121517
UMLS CUI [4]
C0577628
UMLS CUI [5,1]
C0577628
UMLS CUI [5,2]
C0750491
UMLS CUI [6]
C1275435
UMLS CUI [7]
C3875439
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.
Beschrijving

Hepatitis B immune globulin | Immune serum globulin given | Blood product | Blood product Required

Datatype

boolean

Alias
UMLS CUI [1]
C0062525
UMLS CUI [2]
C0486994
UMLS CUI [3]
C0456388
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1514873
*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.
Beschrijving

Vaccines, Inactivated

Datatype

boolean

Alias
UMLS CUI [1]
C0042212
participant has received investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
Beschrijving

Investigational New Drugs | INVESTIGATIONAL VACCINES

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1875384
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).
Beschrijving

Therapeutic immunosuppression | Adrenal Cortex Hormones Dose Systemic | Prednisone Dose U/day | Exception Topical Steroid Therapy | Exception Inhaled steroid therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205373
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3897353
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C4039912
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).
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods | Female Condoms | Vaginal contraceptive diaphragm | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant Hormonal

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0021900
UMLS CUI [9,1]
C1657106
UMLS CUI [9,2]
C0458083
participant has any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Beschrijving

Condition Interferes with Evaluation Research data

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0681873
participant has a coagulation disorder contraindicating intramuscular injection.
Beschrijving

Blood Coagulation Disorders | Intramuscular injection Contraindicated

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0021492
UMLS CUI [2,2]
C1444657
participant has immunocompromised condition (such as human immunodeficiency virus (hiv) positive, leukemia, lymphoma, other cancers or disorders).
Beschrijving

Immunocompromised patient | HIV Seropositivity | Leukemia | Lymphoma | Cancer Other | Disease Other

Datatype

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0019699
UMLS CUI [3]
C0023418
UMLS CUI [4]
C0024299
UMLS CUI [5]
C1707251
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205394
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Similar models

Eligibility Hepatitis B NCT01463683

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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