ID

17357

Beschreibung

Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00325143

Link

https://clinicaltrials.gov/show/NCT00325143

Stichworte

Versionen (1)
  1. 07.09.16 07.09.16 -
Hochgeladen am

7. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diphtheria, Tetanus, Pertussis, Hepatitis B, Polio, Haemophilus Influenzae Type B NCT00325143

Englisch

Eligibility Diphtheria, Tetanus, Pertussis, Hepatitis B, Polio, Haemophilus Influenzae Type B NCT00325143

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have been enrolled in the rota-028 study.
Beschreibung

Enrollment Clinical Trial Preceding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0332152
subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Beschreibung

Protocol Compliance parent | Protocol Compliance Guardian

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
a male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the parent or guardian of the subject.
Beschreibung

Informed Consent parent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

Disease Free of | examination; clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332296
UMLS CUI [2]
C1456356
subjects should have received two doses of hepatitis b vaccine: at birth and at approximately one month of age.
Beschreibung

Hepatitis B vaccination Dosage Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
Beschreibung

Immunosuppressive Agents Administration chronic | Biological Response Modifiers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205191
UMLS CUI [2]
C0005525
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
Beschreibung

Vaccine Illicit Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C2348563
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Beschreibung

Immunosuppression | Immunologic Deficiency Syndromes | HIV Infections

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019693
a family history of congenital or hereditary immunodeficiency.
Beschreibung

Immunodeficiency congenital Family history | Immunodeficiency Hereditary Family history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

History of allergies | history of allergic reaction | Exacerbation Probably Due to Vaccine Component

Datentyp

boolean

Alias
UMLS CUI [1]
C0489531
UMLS CUI [2]
C2106654
UMLS CUI [3,1]
C0235874
UMLS CUI [3,2]
C0750492
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0042210
UMLS CUI [3,5]
C1705248
major congenital defects or serious chronic illness.
Beschreibung

Congenital Abnormality Major | Chronic disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
history of any neurologic disorders or seizures.
Beschreibung

nervous system disorder | Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
acute disease at the time of enrolment.
Beschreibung

Acute Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beschreibung

Immunoglobulins | Blood product | Immunoglobulins Administration Planned | Blood product Administration Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1533734
UMLS CUI [4,3]
C1301732
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Ähnliche Modelle

Eligibility Diphtheria, Tetanus, Pertussis, Hepatitis B, Polio, Haemophilus Influenzae Type B NCT00325143

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Enrollment Clinical Trial Preceding
Item
subjects must have been enrolled in the rota-028 study.
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Protocol Compliance parent | Protocol Compliance Guardian
Item
subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Age
Item
a male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
Informed Consent parent | Informed Consent Guardian
Item
written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Disease Free of | examination; clinical
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C1456356 (UMLS CUI [2])
Hepatitis B vaccination Dosage Quantity
Item
subjects should have received two doses of hepatitis b vaccine: at birth and at approximately one month of age.
boolean
C0474232 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Immunosuppressive Agents Administration chronic | Biological Response Modifiers
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2])
Vaccine Illicit Study Protocol
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunosuppression | Immunologic Deficiency Syndromes | HIV Infections
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Immunodeficiency congenital Family history | Immunodeficiency Hereditary Family history
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
History of allergies | history of allergic reaction | Exacerbation Probably Due to Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0489531 (UMLS CUI [1])
C2106654 (UMLS CUI [2])
C0235874 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0042210 (UMLS CUI [3,4])
C1705248 (UMLS CUI [3,5])
Congenital Abnormality Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
nervous system disorder | Seizures
Item
history of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins | Blood product | Immunoglobulins Administration Planned | Blood product Administration Planned
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])
C0021027 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0456388 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
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