ID

39554

Description

Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns; ODM derived from: https://clinicaltrials.gov/show/NCT01349283

Lien

https://clinicaltrials.gov/show/NCT01349283

Mots-clés

Versions (1)
  1. 27/01/2020 27/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01349283

Anglais

Eligibility Hepatitis B NCT01349283

1 Formulaires  
Criteria
Description

Criteria

neonates whose mothers are positive for both hbsag and hbeag
Description

Infant, Newborn | Mother Hepatitis B surface antigen positive | Mother Hepatitis B e antigen positive

Type de données

boolean

Alias
UMLS CUI [1]
C0021289
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0149709
UMLS CUI [3,1]
C0026591
UMLS CUI [3,2]
C0392390
neonates whose mothers are positive for only hbsag
Description

Infant, Newborn | Mother Hepatitis B surface antigen positive

Type de données

boolean

Alias
UMLS CUI [1]
C0021289
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0149709
neonates whose mothers are negative for both hbsag and hbeag
Description

Infant, Newborn | Mother Hepatitis B surface antigen negative | Mother Hepatitis B e antigen negative

Type de données

boolean

Alias
UMLS CUI [1]
C0021289
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0919711
UMLS CUI [3,1]
C0026591
UMLS CUI [3,2]
C0948827
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
full-term neonates with gestational age from 37 weeks to 42 weeks;
Description

Neonates Full Term | Gestational Age

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021289
UMLS CUI [1,2]
C3814420
UMLS CUI [2]
C0017504
apgar scores are no less than 7 at birth;
Description

Apgar Score at birth

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003533
UMLS CUI [1,2]
C2599577
neonates with standard body temperature (auxiliary temperature < 37.1°);
Description

Neonates Standard Body Temperature

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021289
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0005903
neonates weighing ≥ 2,500 grams at birth;
Description

Neonates Body Weight at birth

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021289
UMLS CUI [1,2]
C0005910
UMLS CUI [1,3]
C2599577
neonates with icteric index within the normal range (physiologic jaundice is permitted);
Description

Infant, Newborn | Icteric Index Normal | Newborn physiological jaundice allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0021289
UMLS CUI [2,1]
C1829782
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C1565887
UMLS CUI [3,2]
C0683607
informed consent form signed by parent/guardian;
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
the requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.
Description

Study Protocol Requirement

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1514873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject's parent has a history of family diseases such as convulsion and brain diseases;
Description

Parent History of Family illness | Parent Convulsions | Parent Brain Diseases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0332119
UMLS CUI [1,3]
C0344339
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C4048158
UMLS CUI [3,1]
C0030551
UMLS CUI [3,2]
C0006111
mothers have low immunologic function or a history of organ transplantation or hemodialysis;
Description

Mother | Immunologic function low | History of Organ Transplantation | History of Hemodialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0026591
UMLS CUI [2,1]
C1817756
UMLS CUI [2,2]
C0205251
UMLS CUI [3,1]
C0332119
UMLS CUI [3,2]
C0029216
UMLS CUI [4,1]
C0332119
UMLS CUI [4,2]
C0019004
subject's parent is allergic to any composition of hepatitis b vaccine;
Description

Parent | Hypersensitivity Composition Hepatitis B vaccine

Type de données

boolean

Alias
UMLS CUI [1]
C0030551
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0486616
UMLS CUI [2,3]
C2066344
a family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
Description

Family history Thrombocytopenia | Family history Blood Coagulation Disorders | Medical contraindication Intramuscular injection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0040034
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0005779
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0021492
known immunologic function damage;
Description

Immunologic function Impairment

Type de données

boolean

Alias
UMLS CUI [1,1]
C1817756
UMLS CUI [1,2]
C0221099
mothers had received gamma globulin or immunoglobulin injection during pregnancy;
Description

Mother | Gamma globulin Injection During Pregnancy | Immunoglobulin Injection During Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0026591
UMLS CUI [2,1]
C0017007
UMLS CUI [2,2]
C1533685
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0032961
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1533685
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0032961
any congenital malformation
Description

Congenital Abnormality

Type de données

boolean

Alias
UMLS CUI [1]
C0000768
known or suspected to suffer from diseases such as active infection and cardiovascular disease;
Description

Communicable Disease | Communicable Disease Suspected | Cardiovascular Disease | Cardiovascular Disease Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0007222
UMLS CUI [4,1]
C0007222
UMLS CUI [4,2]
C0750491
any condition believed by the investigator to have possible impact on trial evaluation.
Description

Condition Impact Trial Evaluation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1261322
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Similar models

Eligibility Hepatitis B NCT01349283

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Infant, Newborn | Mother Hepatitis B surface antigen positive | Mother Hepatitis B e antigen positive
Item
neonates whose mothers are positive for both hbsag and hbeag
boolean
C0021289 (UMLS CUI [1])
C0026591 (UMLS CUI [2,1])
C0149709 (UMLS CUI [2,2])
C0026591 (UMLS CUI [3,1])
C0392390 (UMLS CUI [3,2])
Infant, Newborn | Mother Hepatitis B surface antigen positive
Item
neonates whose mothers are positive for only hbsag
boolean
C0021289 (UMLS CUI [1])
C0026591 (UMLS CUI [2,1])
C0149709 (UMLS CUI [2,2])
Infant, Newborn | Mother Hepatitis B surface antigen negative | Mother Hepatitis B e antigen negative
Item
neonates whose mothers are negative for both hbsag and hbeag
boolean
C0021289 (UMLS CUI [1])
C0026591 (UMLS CUI [2,1])
C0919711 (UMLS CUI [2,2])
C0026591 (UMLS CUI [3,1])
C0948827 (UMLS CUI [3,2])
Item Group
C1512693 (UMLS CUI)
Neonates Full Term | Gestational Age
Item
full-term neonates with gestational age from 37 weeks to 42 weeks;
boolean
C0021289 (UMLS CUI [1,1])
C3814420 (UMLS CUI [1,2])
C0017504 (UMLS CUI [2])
Apgar Score at birth
Item
apgar scores are no less than 7 at birth;
boolean
C0003533 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Neonates Standard Body Temperature
Item
neonates with standard body temperature (auxiliary temperature < 37.1°);
boolean
C0021289 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Neonates Body Weight at birth
Item
neonates weighing ≥ 2,500 grams at birth;
boolean
C0021289 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C2599577 (UMLS CUI [1,3])
Infant, Newborn | Icteric Index Normal | Newborn physiological jaundice allowed
Item
neonates with icteric index within the normal range (physiologic jaundice is permitted);
boolean
C0021289 (UMLS CUI [1])
C1829782 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1565887 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Informed Consent Parent | Informed Consent Guardian
Item
informed consent form signed by parent/guardian;
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Study Protocol Requirement
Item
the requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.
boolean
C2348563 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Parent History of Family illness | Parent Convulsions | Parent Brain Diseases
Item
subject's parent has a history of family diseases such as convulsion and brain diseases;
boolean
C0030551 (UMLS CUI [1,1])
C0332119 (UMLS CUI [1,2])
C0344339 (UMLS CUI [1,3])
C0030551 (UMLS CUI [2,1])
C4048158 (UMLS CUI [2,2])
C0030551 (UMLS CUI [3,1])
C0006111 (UMLS CUI [3,2])
Mother | Immunologic function low | History of Organ Transplantation | History of Hemodialysis
Item
mothers have low immunologic function or a history of organ transplantation or hemodialysis;
boolean
C0026591 (UMLS CUI [1])
C1817756 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0332119 (UMLS CUI [3,1])
C0029216 (UMLS CUI [3,2])
C0332119 (UMLS CUI [4,1])
C0019004 (UMLS CUI [4,2])
Parent | Hypersensitivity Composition Hepatitis B vaccine
Item
subject's parent is allergic to any composition of hepatitis b vaccine;
boolean
C0030551 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0486616 (UMLS CUI [2,2])
C2066344 (UMLS CUI [2,3])
Family history Thrombocytopenia | Family history Blood Coagulation Disorders | Medical contraindication Intramuscular injection
Item
a family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
boolean
C0241889 (UMLS CUI [1,1])
C0040034 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0005779 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0021492 (UMLS CUI [3,2])
Immunologic function Impairment
Item
known immunologic function damage;
boolean
C1817756 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
Mother | Gamma globulin Injection During Pregnancy | Immunoglobulin Injection During Pregnancy
Item
mothers had received gamma globulin or immunoglobulin injection during pregnancy;
boolean
C0026591 (UMLS CUI [1])
C0017007 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0032961 (UMLS CUI [2,4])
C0021027 (UMLS CUI [3,1])
C1533685 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0032961 (UMLS CUI [3,4])
Congenital Abnormality
Item
any congenital malformation
boolean
C0000768 (UMLS CUI [1])
Communicable Disease | Communicable Disease Suspected | Cardiovascular Disease | Cardiovascular Disease Suspected
Item
known or suspected to suffer from diseases such as active infection and cardiovascular disease;
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0007222 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Condition Impact Trial Evaluation
Item
any condition believed by the investigator to have possible impact on trial evaluation.
boolean
C0348080 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
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