ID

39548

Description

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

Lien

https://clinicaltrials.gov/show/NCT02445703

Mots-clés

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

See clinicaltrials.gov

Téléchargé le

26 janvier 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hepatitis A NCT02445703

Anglais

Eligibility Hepatitis A NCT02445703

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Infant Healthy | Age

Type de données

boolean

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

Hepatitis A Vaccine Vaccination Absent

Type de données

boolean

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

Hepatitis B vaccination Completed

Type de données

boolean

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

Informed Consent Guardian

Type de données

boolean

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

Exclusion Criteria Injection First

Type de données

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;
Description

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

Type de données

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;
Description

Autoimmune Disease | Immunodeficiency

Type de données

boolean

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

Acute Disease | Condition Inappropriate Vaccination

Type de données

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;
Description

Vaccines, Attenuated

Type de données

boolean

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

Vaccines, Subunit | Vaccines, Inactivated

Type de données

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;
Description

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

Type de données

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;
Description

Body temperature measurement | Status pre- Injection

Type de données

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;
Description

Study Subject Participation Status Inappropriate

Type de données

boolean

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

Exclusion Criteria Injection second

Type de données

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;
Description

Communicable Disease | Body temperature measurement | Attacks Chronic disease

Type de données

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;
Description

Administration Blood product | Investigational New Drugs

Type de données

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;
Description

Adverse event Grade | Relationship Injection First

Type de données

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;
Description

Study Subject Participation Status Excluded | Investigator Decision

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0035173
UMLS CUI [2,2]
C0679006
Retour au début de la page

Similar models

Eligibility Hepatitis A NCT02445703

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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