ID

42765

Description

Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.; ODM derived from: https://clinicaltrials.gov/show/NCT00316680

Link

https://clinicaltrials.gov/show/NCT00316680

Keywords

Versions (2)
  1. 3/20/17 3/20/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Haemophilus Influenzae Type b Disease NCT00316680

English

Eligibility Haemophilus Influenzae Type b Disease NCT00316680

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
administration of one dose of hepatitis b vaccine at birth.
Description

Hepatitis B Vaccine Dose Quantity at birth

Data type

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C2599577
a healthy male or female between, and including, 6 and 12 weeks of age at the time of the first dtpw vaccination.
Description

Healthy Volunteers | Age | Diphtheria-Tetanus-(whole-cell) Pertussis Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1277100
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered product (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.
Description

Investigational New Drugs | Vaccine Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Description

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis b vaccine for the triple antigen + hib group.
Description

Vaccine | Oral Poliovirus Vaccine | Hepatitis B Vaccine | Diphtheria, pertussis and tetanus triple vaccination | Vaccinations against hemophilus influenza, type B [Hib]

Data type

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C0032375
UMLS CUI [3]
C2240392
UMLS CUI [4]
C1302169
UMLS CUI [5]
C0375765
any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
Description

Immunosuppression | Immunodeficiency | Immunosuppression Suspected | Immunodeficiency Suspected | Medical History | Physical Examination | Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0262926
UMLS CUI [6]
C0031809
UMLS CUI [7]
C0022885
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Description

Immunoglobulins | Blood product

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
bacille calmette-guérin (bcg) vaccine given after the first 2 weeks of life.
Description

BCG Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0004886
previous vaccination against diphtheria, tetanus, pertussis and/or hib/history of diphteria, tetanus, pertussis, hepatitis b and/ or hib disease.
Description

Diphtheria vaccination | Tetanus vaccination | Pertussis vaccination | Vaccinations against hemophilus influenza, type B [Hib] | Diphtheria | Tetanus | Pertussis | Hepatitis B | Haemophilus influenzae type b infection

Data type

boolean

Alias
UMLS CUI [1]
C0199806
UMLS CUI [2]
C0199807
UMLS CUI [3]
C0042203
UMLS CUI [4]
C0375765
UMLS CUI [5]
C0012546
UMLS CUI [6]
C0039614
UMLS CUI [7]
C0043167
UMLS CUI [8]
C0019163
UMLS CUI [9]
C2028293
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Similar models

Eligibility Haemophilus Influenzae Type b Disease NCT00316680

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B Vaccine Dose Quantity at birth
Item
administration of one dose of hepatitis b vaccine at birth.
boolean
C2240392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2599577 (UMLS CUI [1,4])
Healthy Volunteers | Age | Diphtheria-Tetanus-(whole-cell) Pertussis Vaccine
Item
a healthy male or female between, and including, 6 and 12 weeks of age at the time of the first dtpw vaccination.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1277100 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Vaccine Investigational
Item
use of any investigational or non-registered product (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])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration 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])
Vaccine | Oral Poliovirus Vaccine | Hepatitis B Vaccine | Diphtheria, pertussis and tetanus triple vaccination | Vaccinations against hemophilus influenza, type B [Hib]
Item
planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis b vaccine for the triple antigen + hib group.
boolean
C0042210 (UMLS CUI [1])
C0032375 (UMLS CUI [2])
C2240392 (UMLS CUI [3])
C1302169 (UMLS CUI [4])
C0375765 (UMLS CUI [5])
Immunosuppression | Immunodeficiency | Immunosuppression Suspected | Immunodeficiency Suspected | Medical History | Physical Examination | Laboratory Procedures
Item
any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0022885 (UMLS CUI [7])
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])
BCG Vaccine
Item
bacille calmette-guérin (bcg) vaccine given after the first 2 weeks of life.
boolean
C0004886 (UMLS CUI [1])
Diphtheria vaccination | Tetanus vaccination | Pertussis vaccination | Vaccinations against hemophilus influenza, type B [Hib] | Diphtheria | Tetanus | Pertussis | Hepatitis B | Haemophilus influenzae type b infection
Item
previous vaccination against diphtheria, tetanus, pertussis and/or hib/history of diphteria, tetanus, pertussis, hepatitis b and/ or hib disease.
boolean
C0199806 (UMLS CUI [1])
C0199807 (UMLS CUI [2])
C0042203 (UMLS CUI [3])
C0375765 (UMLS CUI [4])
C0012546 (UMLS CUI [5])
C0039614 (UMLS CUI [6])
C0043167 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
C2028293 (UMLS CUI [9])
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