ID

17559

Beschreibung

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.; ODM derived from: https://clinicaltrials.gov/show/NCT00317187

Link

https://clinicaltrials.gov/show/NCT00317187

Stichworte

Versionen (1)
  1. 23.09.16 23.09.16 -
Hochgeladen am

23. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hib Disease NCT00317187

Englisch

Eligibility Hib Disease NCT00317187

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
• healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis b vaccine within the first 3 days of life.
Beschreibung

infant appeared healthy at birth | Age | Informed Consent parent | Duration of gestation | Hepatitis B Vaccine Dose Birth time

Datentyp

boolean

Alias
UMLS CUI [1]
C2049683
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4]
C0460089
UMLS CUI [5,1]
C2240392
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C2736116
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any confirmed immunodeficient condition, based on medical history and physical examination.
Beschreibung

Immunologic Deficiency Syndromes | Medical History | Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (opv).
Beschreibung

Vaccine Planned | Oral Poliovirus Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0032375
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beschreibung

Investigational New Drugs | Drugs, Non-Prescription | Vaccine Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Beschreibung

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life.
Beschreibung

BCG Vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C0004886
previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b, and/or meningococcal disease.
Beschreibung

Vaccination Against Diphtheria | Vaccination Against Tetanus | Vaccination Against Pertussis | Vaccination Against Haemophilus influenzae type b | Vaccination Against Meningococcal Infections

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0012546
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0039614
UMLS CUI [3,1]
C0042196
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0043167
UMLS CUI [4,1]
C0042196
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0121772
UMLS CUI [5,1]
C0042196
UMLS CUI [5,2]
C0521124
UMLS CUI [5,3]
C0025303
history of diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
Beschreibung

Exposure to Diphtheria | Exposure to Tetanus | Exposure to Pertussis | Exposure to Hepatitis B | Exposure to Haemophilus influenzae type b | Exposure to Meningococcal Infections

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0012546
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0039614
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0043167
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0019163
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0121772
UMLS CUI [6,1]
C0332157
UMLS CUI [6,2]
C0025303
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beschreibung

Immunoglobulins | Blood product

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
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Ähnliche Modelle

Eligibility Hib Disease NCT00317187

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
infant appeared healthy at birth | Age | Informed Consent parent | Duration of gestation | Hepatitis B Vaccine Dose Birth time
Item
• healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis b vaccine within the first 3 days of life.
boolean
C2049683 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0460089 (UMLS CUI [4])
C2240392 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C2736116 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Immunologic Deficiency Syndromes | Medical History | Physical Examination
Item
any confirmed immunodeficient condition, based on medical history and physical examination.
boolean
C0021051 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Vaccine Planned | Oral Poliovirus Vaccine
Item
planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (opv).
boolean
C0042210 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0032375 (UMLS CUI [2])
Investigational New Drugs | Drugs, Non-Prescription | Vaccine Investigational
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
BCG Vaccine
Item
bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life.
boolean
C0004886 (UMLS CUI [1])
Vaccination Against Diphtheria | Vaccination Against Tetanus | Vaccination Against Pertussis | Vaccination Against Haemophilus influenzae type b | Vaccination Against Meningococcal Infections
Item
previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b, and/or meningococcal disease.
boolean
C0042196 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0039614 (UMLS CUI [2,3])
C0042196 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0043167 (UMLS CUI [3,3])
C0042196 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0121772 (UMLS CUI [4,3])
C0042196 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0025303 (UMLS CUI [5,3])
Exposure to Diphtheria | Exposure to Tetanus | Exposure to Pertussis | Exposure to Hepatitis B | Exposure to Haemophilus influenzae type b | Exposure to Meningococcal Infections
Item
history of diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
boolean
C0332157 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0039614 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0043167 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0121772 (UMLS CUI [5,2])
C0332157 (UMLS CUI [6,1])
C0025303 (UMLS CUI [6,2])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
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