ID

39544

Description

Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines; ODM derived from: https://clinicaltrials.gov/show/NCT01252680

Lien

https://clinicaltrials.gov/show/NCT01252680

Mots-clés

Versions (1)
  1. 26/01/2020 26/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

26 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatitis A NCT01252680

Anglais

Eligibility Hepatitis A NCT01252680

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy children aged between 1.5 and 5 years, with no history of hepatitis a virus infection or hepatitis a vaccine vaccination
Description

Healthy child | Age | History of hepatitis A Absent | Hepatitis A Vaccine Vaccination Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0686744
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1997459
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0170300
UMLS CUI [4,2]
C0042196
UMLS CUI [4,3]
C0332197
provided birth certification or vaccination card
Description

Birth Certificate | Vaccination Card

Type de données

boolean

Alias
UMLS CUI [1]
C0005600
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C3275277
parent(s) or legal guardian(s) are able to understand and sign the informed consent
Description

Informed Consent Parent | Informed Consent Guardian

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
axillary temperature > 37.0 centigrade at the time of dosing
Description

Axillary temperature

Type de données

boolean

Alias
UMLS CUI [1]
C1531924
subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
Description

History of allergic reaction | Allergic Reaction Vaccine Ingredient

Type de données

boolean

Alias
UMLS CUI [1]
C2106654
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C1550600
serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Description

Adverse reactions Serious Vaccines | Anaphylaxis | Urticaria | Dyspnea | Angioedema | Abdominal Pain

Type de données

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0042210
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0042109
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0002994
UMLS CUI [6]
C0000737
autoimmune disease or immunodeficiency
Description

Autoimmune Disease | Immunodeficiency

Type de données

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
congenital malformation, developmental disorders or serious chronic diseases (such as down's syndrome, diabetes, sickle cell anemia or neurological disorders)
Description

Congenital Abnormality | Developmental Disabilities | Chronic disease Serious | Down Syndrome | Diabetes Mellitus | Anemia, Sickle Cell | Nervous system disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0000768
UMLS CUI [2]
C0008073
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0013080
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0002895
UMLS CUI [7]
C0027765
bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws
Description

Blood Coagulation Disorders | Coagulation factor deficiency | Blood Platelet Disorders | Contusions | Hemorrhage Difficulty | Intramuscular injection | Blood draw

Type de données

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0272315
UMLS CUI [3]
C0005818
UMLS CUI [4]
C0009938
UMLS CUI [5,1]
C0019080
UMLS CUI [5,2]
C0332218
UMLS CUI [6]
C0021492
UMLS CUI [7]
C0005834
history or family history of convulsions, epilepsy, brain disease and psychiatric
Description

Convulsions | History of Epilepsy | Family history of Epilepsy | History of brain disorder | Family history of Brain disorder | History of psychiatric disorder | Family history of mental disorder

Type de données

boolean

Alias
UMLS CUI [1]
C4048158
UMLS CUI [2]
C0455511
UMLS CUI [3]
C0455392
UMLS CUI [4]
C0455685
UMLS CUI [5]
C0455680
UMLS CUI [6]
C0455498
UMLS CUI [7]
C0455379
history of any blood products within 3 months
Description

Blood product

Type de données

boolean

Alias
UMLS CUI [1]
C0456388
administration of any other investigational research agents within 30 days
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
administration of any live attenuated vaccine within 30 days
Description

Vaccines, Attenuated

Type de données

boolean

Alias
UMLS CUI [1]
C0042211
administration of subunit or inactivated vaccines within 14 days
Description

Vaccines, Subunit | Vaccines, Inactivated

Type de données

boolean

Alias
UMLS CUI [1]
C0887892
UMLS CUI [2]
C0042212
any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Description

Medical condition Study Subject Participation Status Contraindicated | Medical condition Impairing Informed Consent | Mental condition Study Subject Participation Status Contraindicated | Mental condition Impairing Informed Consent | Social Condition Study Subject Participation Status Contraindicated | Social Condition Impairing Informed Consent | Factor Occupational Study Subject Participation Status Contraindicated | Factor Occupational Impairing Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444657
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C0021430
UMLS CUI [5,1]
C0037403
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444657
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0221099
UMLS CUI [6,3]
C0021430
UMLS CUI [7,1]
C1521761
UMLS CUI [7,2]
C0521127
UMLS CUI [7,3]
C2348568
UMLS CUI [7,4]
C1444657
UMLS CUI [8,1]
C1521761
UMLS CUI [8,2]
C0521127
UMLS CUI [8,3]
C0221099
UMLS CUI [8,4]
C0021430
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Similar models

Eligibility Hepatitis A NCT01252680

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Healthy child | Age | History of hepatitis A Absent | Hepatitis A Vaccine Vaccination Absent
Item
healthy children aged between 1.5 and 5 years, with no history of hepatitis a virus infection or hepatitis a vaccine vaccination
boolean
C0686744 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1997459 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0170300 (UMLS CUI [4,1])
C0042196 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Birth Certificate | Vaccination Card
Item
provided birth certification or vaccination card
boolean
C0005600 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C3275277 (UMLS CUI [2,2])
Informed Consent Parent | Informed Consent Guardian
Item
parent(s) or legal guardian(s) are able to understand and sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Axillary temperature
Item
axillary temperature > 37.0 centigrade at the time of dosing
boolean
C1531924 (UMLS CUI [1])
History of allergic reaction | Allergic Reaction Vaccine Ingredient
Item
subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
boolean
C2106654 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Adverse reactions Serious Vaccines | Anaphylaxis | Urticaria | Dyspnea | Angioedema | Abdominal Pain
Item
serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
boolean
C0559546 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2])
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])
Congenital Abnormality | Developmental Disabilities | Chronic disease Serious | Down Syndrome | Diabetes Mellitus | Anemia, Sickle Cell | Nervous system disorder
Item
congenital malformation, developmental disorders or serious chronic diseases (such as down's syndrome, diabetes, sickle cell anemia or neurological disorders)
boolean
C0000768 (UMLS CUI [1])
C0008073 (UMLS CUI [2])
C0008679 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0013080 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0002895 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
Blood Coagulation Disorders | Coagulation factor deficiency | Blood Platelet Disorders | Contusions | Hemorrhage Difficulty | Intramuscular injection | Blood draw
Item
bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws
boolean
C0005779 (UMLS CUI [1])
C0272315 (UMLS CUI [2])
C0005818 (UMLS CUI [3])
C0009938 (UMLS CUI [4])
C0019080 (UMLS CUI [5,1])
C0332218 (UMLS CUI [5,2])
C0021492 (UMLS CUI [6])
C0005834 (UMLS CUI [7])
Convulsions | History of Epilepsy | Family history of Epilepsy | History of brain disorder | Family history of Brain disorder | History of psychiatric disorder | Family history of mental disorder
Item
history or family history of convulsions, epilepsy, brain disease and psychiatric
boolean
C4048158 (UMLS CUI [1])
C0455511 (UMLS CUI [2])
C0455392 (UMLS CUI [3])
C0455685 (UMLS CUI [4])
C0455680 (UMLS CUI [5])
C0455498 (UMLS CUI [6])
C0455379 (UMLS CUI [7])
Blood product
Item
history of any blood products within 3 months
boolean
C0456388 (UMLS CUI [1])
Investigational New Drugs
Item
administration of any other investigational research agents within 30 days
boolean
C0013230 (UMLS CUI [1])
Vaccines, Attenuated
Item
administration of any live attenuated vaccine within 30 days
boolean
C0042211 (UMLS CUI [1])
Vaccines, Subunit | Vaccines, Inactivated
Item
administration of subunit or inactivated vaccines within 14 days
boolean
C0887892 (UMLS CUI [1])
C0042212 (UMLS CUI [2])
Medical condition Study Subject Participation Status Contraindicated | Medical condition Impairing Informed Consent | Mental condition Study Subject Participation Status Contraindicated | Mental condition Impairing Informed Consent | Social Condition Study Subject Participation Status Contraindicated | Social Condition Impairing Informed Consent | Factor Occupational Study Subject Participation Status Contraindicated | Factor Occupational Impairing Informed Consent
Item
any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C0037403 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444657 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0221099 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C1521761 (UMLS CUI [7,1])
C0521127 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C1444657 (UMLS CUI [7,4])
C1521761 (UMLS CUI [8,1])
C0521127 (UMLS CUI [8,2])
C0221099 (UMLS CUI [8,3])
C0021430 (UMLS CUI [8,4])
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