ID

36063

Description

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli); ODM derived from: https://clinicaltrials.gov/show/NCT02417597

Link

https://clinicaltrials.gov/show/NCT02417597

Keywords

Versions (2)
  1. 4/12/19 4/12/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 12, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis E NCT02417597

English

Eligibility Hepatitis E NCT02417597

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy people aged over 18 years old on the day of enrollment
Description

Healthy Volunteers | Age

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
2. axillary temperature is below than 37.0 ℃
Description

Axillary temperature

Data type

boolean

Alias
UMLS CUI [1]
C1531924
3. blood pressure is not higher than 160/100 mmhg (with or without any medicine)
Description

Blood pressure determination | Pharmaceutical Preparations | Pharmaceutical Preparations Absent

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2]
C0013227
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332197
4. judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
Description

Healthy | Patient Eligible Vaccination | Medical History | Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0042196
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0031809
5. able to understand this study information and willing to comply with all study requirements.
Description

Comprehension Study Protocol | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
6. willing to participate in this study and sign informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participated in any other clinical trial during the study period.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
2. use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
Description

Investigational New Drugs | Drugs, Non-Prescription | Vaccines

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042210
3. received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
Description

Therapeutic immunosuppression | Immunoregulation Therapy | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Local Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0678889
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C3653708
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1517925
4. administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
Description

Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1301732
5. administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
Description

Vaccines, Inactivated | Vaccines, Attenuated

Data type

boolean

Alias
UMLS CUI [1]
C0042212
UMLS CUI [2]
C0042211
6. had a fever (axillary temperature over 38°c) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
Description

Fever | Axillary temperature | Acute illness Requirement Antibiotics for systemic use | Acute illness Requirement Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C1531924
UMLS CUI [3,1]
C4061114
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3540704
UMLS CUI [4,1]
C4061114
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0280274
7. immunodeficiency (such as hiv carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
Description

Immunodeficiency | HIV carrier | Disease Organ Important | Malignant Neoplasms | Immune System Diseases | Lupus Erythematosus, Systemic | Other Coding | Splenectomy | Functional asplenia | Disease Affecting Immune response

Data type

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0853961
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0178784
UMLS CUI [3,3]
C3898777
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0024141
UMLS CUI [7]
C3846158
UMLS CUI [8]
C0037995
UMLS CUI [9]
C0272405
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0301872
8. history of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Description

Disease allergic | Serious Adverse Event Post Vaccination | Hypersensitivity | Urticaria | Dyspnea | Angioedema | Abdominal Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0700624
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0042196
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0042109
UMLS CUI [5]
C0013404
UMLS CUI [6]
C0002994
UMLS CUI [7]
C0000737
9. pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. allergic history to any component of this vaccine.
Description

Hypersensitivity Vaccines Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
11. other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.
Description

Medical condition Affecting Protocol Compliance | Psychological Factors Affecting Protocol Compliance | Social factor Affecting Protocol Compliance | Factor Occupational Affecting Protocol Compliance | Medical condition Affecting Informed Consent | Psychological Factors Affecting Informed Consent | Social factor Affecting Informed Consent | Factor Occupational Affecting Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0033898
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0337460
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C0521127
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C0033898
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0021430
UMLS CUI [7,1]
C0337460
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C0021430
UMLS CUI [8,1]
C1521761
UMLS CUI [8,2]
C0521127
UMLS CUI [8,3]
C0392760
UMLS CUI [8,4]
C0021430
Back to the top of the page

Similar models

Eligibility Hepatitis E NCT02417597

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Age
Item
1. healthy people aged over 18 years old on the day of enrollment
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Axillary temperature
Item
2. axillary temperature is below than 37.0 ℃
boolean
C1531924 (UMLS CUI [1])
Blood pressure determination | Pharmaceutical Preparations | Pharmaceutical Preparations Absent
Item
3. blood pressure is not higher than 160/100 mmhg (with or without any medicine)
boolean
C0005824 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Healthy | Patient Eligible Vaccination | Medical History | Physical Examination
Item
4. judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
boolean
C3898900 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
Comprehension Study Protocol | Protocol Compliance
Item
5. able to understand this study information and willing to comply with all study requirements.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
6. willing to participate in this study and sign informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
1. participated in any other clinical trial during the study period.
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription | Vaccines
Item
2. use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Therapeutic immunosuppression | Immunoregulation Therapy | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Local Therapy
Item
3. received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
boolean
C0021079 (UMLS CUI [1])
C0678889 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1517925 (UMLS CUI [4,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
4. administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Vaccines, Inactivated | Vaccines, Attenuated
Item
5. administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
boolean
C0042212 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
Fever | Axillary temperature | Acute illness Requirement Antibiotics for systemic use | Acute illness Requirement Antiviral Therapy
Item
6. had a fever (axillary temperature over 38°c) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
boolean
C0015967 (UMLS CUI [1])
C1531924 (UMLS CUI [2])
C4061114 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3540704 (UMLS CUI [3,3])
C4061114 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0280274 (UMLS CUI [4,3])
Immunodeficiency | HIV carrier | Disease Organ Important | Malignant Neoplasms | Immune System Diseases | Lupus Erythematosus, Systemic | Other Coding | Splenectomy | Functional asplenia | Disease Affecting Immune response
Item
7. immunodeficiency (such as hiv carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
boolean
C0021051 (UMLS CUI [1])
C0853961 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C3898777 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0024141 (UMLS CUI [6])
C3846158 (UMLS CUI [7])
C0037995 (UMLS CUI [8])
C0272405 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0301872 (UMLS CUI [10,3])
Disease allergic | Serious Adverse Event Post Vaccination | Hypersensitivity | Urticaria | Dyspnea | Angioedema | Abdominal Pain
Item
8. history of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
boolean
C0012634 (UMLS CUI [1,1])
C0700624 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
C0013404 (UMLS CUI [5])
C0002994 (UMLS CUI [6])
C0000737 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
9. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Vaccines Component
Item
10. allergic history to any component of this vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Medical condition Affecting Protocol Compliance | Psychological Factors Affecting Protocol Compliance | Social factor Affecting Protocol Compliance | Factor Occupational Affecting Protocol Compliance | Medical condition Affecting Informed Consent | Psychological Factors Affecting Informed Consent | Social factor Affecting Informed Consent | Factor Occupational Affecting Informed Consent
Item
11. other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0033898 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0337460 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C1521761 (UMLS CUI [4,1])
C0521127 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0033898 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0337460 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C1521761 (UMLS CUI [8,1])
C0521127 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0021430 (UMLS CUI [8,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial