ID

39554

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01349283

Trefwoorden

Versies (1)
  1. 27-01-20 27-01-20 -
Houder van rechten

See clinicaltrials.gov

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27 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01349283

Engels

Eligibility Hepatitis B NCT01349283

1 Formulieren  
Criteria
Beschrijving

Criteria

neonates whose mothers are positive for both hbsag and hbeag
Beschrijving

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

Datatype

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
Beschrijving

Infant, Newborn | Mother Hepatitis B surface antigen positive

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Inclusion Criteria

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

Neonates Full Term | Gestational Age

Datatype

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;
Beschrijving

Apgar Score at birth

Datatype

boolean

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

Neonates Standard Body Temperature

Datatype

boolean

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

Neonates Body Weight at birth

Datatype

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);
Beschrijving

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

Datatype

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;
Beschrijving

Informed Consent Parent | Informed Consent Guardian

Datatype

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.
Beschrijving

Study Protocol Requirement

Datatype

boolean

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

Exclusion Criteria

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

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

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

Parent | Hypersensitivity Composition Hepatitis B vaccine

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

Immunologic function Impairment

Datatype

boolean

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

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

Datatype

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
Beschrijving

Congenital Abnormality

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Condition Impact Trial Evaluation

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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