ID

39544

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01252680

Keywords

versioni (1)
  1. 26/01/20 26/01/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

26 gennaio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Hepatitis A NCT01252680

Inglese

Eligibility Hepatitis A NCT01252680

1 moduli  
Inclusion Criteria
Descrizione

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
Descrizione

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

Tipo di dati

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
Descrizione

Birth Certificate | Vaccination Card

Tipo di dati

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
Descrizione

Informed Consent Parent | Informed Consent Guardian

Tipo di dati

boolean

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

Exclusion Criteria

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

Axillary temperature

Tipo di dati

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
Descrizione

History of allergic reaction | Allergic Reaction Vaccine Ingredient

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Autoimmune Disease | Immunodeficiency

Tipo di dati

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)
Descrizione

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Blood product

Tipo di dati

boolean

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

Investigational New Drugs

Tipo di dati

boolean

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

Vaccines, Attenuated

Tipo di dati

boolean

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

Vaccines, Subunit | Vaccines, Inactivated

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Ritorna all'inizio della pagina

Similar models

Eligibility Hepatitis A NCT01252680

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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