ID

39548

Descrição

Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT02445703

Link

https://clinicaltrials.gov/show/NCT02445703

Palavras-chave

Versões (1)
  1. 26/01/2020 26/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis A NCT02445703

Inglês

Eligibility Hepatitis A NCT02445703

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy infants between 18 and 24 months old;
Descrição

Infant Healthy | Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021270
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0001779
have not received hepatitis a vaccine before;
Descrição

Hepatitis A Vaccine Vaccination Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332197
completed hepatitis b vaccine full immunization schedule;
Descrição

Hepatitis B vaccination Completed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0205197
written consent of the guardian of each participant;
Descrição

Informed Consent Guardian

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1274041
exclusion criteria of the first injection:
Descrição

Exclusion Criteria Injection First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0205435
history of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
Descrição

Vaccines allergy | Adverse reactions Serious Vaccination | Urticaria | Dyspnea | Angioedema | Abdominal Pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0571550
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0042196
UMLS CUI [3]
C0042109
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0002994
UMLS CUI [6]
C0000737
autoimmune disease or immunodeficiency;
Descrição

Autoimmune Disease | Immunodeficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
any acute disease that made the conditions of the person unsuitable for vaccination
Descrição

Acute Disease | Condition Inappropriate Vaccination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0042196
administration of any live attenuated vaccine within 14 days prior to the injection;
Descrição

Vaccines, Attenuated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042211
administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
Descrição

Vaccines, Subunit | Vaccines, Inactivated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0887892
UMLS CUI [2]
C0042212
administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;
Descrição

Immunosuppressant drug therapy | Adrenal Cortex Hormones | Immunosuppressant drug therapy Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1096650
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C1096650
UMLS CUI [3,2]
C1301732
body temperature > 37.0 °c before injection;
Descrição

Body temperature measurement | Status pre- Injection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0886414
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1533685
based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
exclusion criteria of the second injection:
Descrição

Exclusion Criteria Injection second

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0205436
any acute infectious disease, body temperature > 38.5 °c or acute attacks of chronic diseases within 3 days prior to the second injection;
Descrição

Communicable Disease | Body temperature measurement | Attacks Chronic disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0886414
UMLS CUI [3,1]
C1304680
UMLS CUI [3,2]
C0008679
administration of blood product or other investigational drug during this study;
Descrição

Administration Blood product | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0456388
UMLS CUI [2]
C0013230
occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
Descrição

Adverse event Grade | Relationship Injection First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C0205435
the investigator or the ethic committee decided that the subject should be excluded;
Descrição

Study Subject Participation Status Excluded | Investigator Decision

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0035173
UMLS CUI [2,2]
C0679006
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Similar models

Eligibility Hepatitis A NCT02445703

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Infant Healthy | Age
Item
healthy infants between 18 and 24 months old;
boolean
C0021270 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Hepatitis A Vaccine Vaccination Absent
Item
have not received hepatitis a vaccine before;
boolean
C0170300 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hepatitis B vaccination Completed
Item
completed hepatitis b vaccine full immunization schedule;
boolean
C0474232 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Informed Consent Guardian
Item
written consent of the guardian of each participant;
boolean
C0021430 (UMLS CUI [1,1])
C1274041 (UMLS CUI [1,2])
Exclusion Criteria Injection First
Item
exclusion criteria of the first injection:
boolean
C0680251 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Vaccines allergy | Adverse reactions Serious Vaccination | Urticaria | Dyspnea | Angioedema | Abdominal Pain
Item
history of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
boolean
C0571550 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0042109 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0002994 (UMLS CUI [5])
C0000737 (UMLS CUI [6])
Autoimmune Disease | Immunodeficiency
Item
autoimmune disease or immunodeficiency;
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Acute Disease | Condition Inappropriate Vaccination
Item
any acute disease that made the conditions of the person unsuitable for vaccination
boolean
C0001314 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Vaccines, Attenuated
Item
administration of any live attenuated vaccine within 14 days prior to the injection;
boolean
C0042211 (UMLS CUI [1])
Vaccines, Subunit | Vaccines, Inactivated
Item
administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
boolean
C0887892 (UMLS CUI [1])
C0042212 (UMLS CUI [2])
Immunosuppressant drug therapy | Adrenal Cortex Hormones | Immunosuppressant drug therapy Planned
Item
administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;
boolean
C1096650 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C1096650 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Body temperature measurement | Status pre- Injection
Item
body temperature > 37.0 °c before injection;
boolean
C0886414 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Exclusion Criteria Injection second
Item
exclusion criteria of the second injection:
boolean
C0680251 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
Communicable Disease | Body temperature measurement | Attacks Chronic disease
Item
any acute infectious disease, body temperature > 38.5 °c or acute attacks of chronic diseases within 3 days prior to the second injection;
boolean
C0009450 (UMLS CUI [1])
C0886414 (UMLS CUI [2])
C1304680 (UMLS CUI [3,1])
C0008679 (UMLS CUI [3,2])
Administration Blood product | Investigational New Drugs
Item
administration of blood product or other investigational drug during this study;
boolean
C1533734 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Adverse event Grade | Relationship Injection First
Item
occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
boolean
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Study Subject Participation Status Excluded | Investigator Decision
Item
the investigator or the ethic committee decided that the subject should be excluded;
boolean
C2348568 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0035173 (UMLS CUI [2,1])
C0679006 (UMLS CUI [2,2])
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