ID

39545

Beschreibung

Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines; ODM derived from: https://clinicaltrials.gov/show/NCT01307436

Link

https://clinicaltrials.gov/show/NCT01307436

Stichworte

Versionen (2)
  1. 26.01.20 26.01.20 -
  2. 26.01.20 26.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Januar 2020

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Hepatitis A NCT01307436

Englisch

Eligibility Hepatitis A NCT01307436

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
original study:
Beschreibung

Clinical Trial Original

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205313
written informed consent obtained from the parent/legal 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/or clinical examination before entering the study.
Beschreibung

Free of Health problem | Medical History | Clinical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0018684
UMLS CUI [1,3]
C0033213
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
at least 8 kg of body weight at age of 12 months.
Beschreibung

Body Weight | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C0001779
follow-up phase:
Beschreibung

Follow-up Phase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1710475
subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines.
Beschreibung

Enrollment Clinical Trial Original | Randomization Clinical Trial Original | Vaccines Dose Quantity | Vaccines Investigational Hepatitis A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205313
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205313
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C1517586
UMLS CUI [4,3]
C0019159
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
original study:
Beschreibung

Clinical Trial Original

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205313
children not having received 3 documented doses of dtpahib and polio vaccines during infancy
Beschreibung

Children | Diphtheria-Tetanus-acellular Pertussis Vaccines Absent | Oral Polio Vaccine Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0535644
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032375
UMLS CUI [3,2]
C0332197
children having received a documented dose of mmr during infancy
Beschreibung

Children | Measles-Mumps-Rubella Vaccine Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0065828
UMLS CUI [2,2]
C0178602
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
Beschreibung

Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C1875384
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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
administration of systemic corticosteroids (inhaled and topical steroids are allowed).
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C3653708
administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
Beschreibung

Vaccine Except Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2348563
previous vaccination against hepatitis a.
Beschreibung

Vaccination Previous Hepatitis A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0019159
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Beschreibung

Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0021051
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4086268
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C4086268
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C1705248
major congenital defects or serious chronic illness
Beschreibung

Congenital defects 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
acute disease at the time of enrolment.
Beschreibung

Acute Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
follow-up phase:
Beschreibung

Follow-up Phase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1710475
children who had received a hepatitis a antigen containing vaccine since the last visit
Beschreibung

Vaccine Containing Hepatitis A Antigen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0062523
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Ähnliche Modelle

Eligibility Hepatitis A NCT01307436

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from the parent/legal 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])
Free of Health problem | Medical History | Clinical Examination
Item
free of obvious health problems as established by medical history and/or clinical examination before entering the study.
boolean
C0332296 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Body Weight | Age
Item
at least 8 kg of body weight at age of 12 months.
boolean
C0005910 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Enrollment Clinical Trial Original | Randomization Clinical Trial Original | Vaccines Dose Quantity | Vaccines Investigational Hepatitis A
Item
subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines.
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205313 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205313 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0042210 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0019159 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Children | Diphtheria-Tetanus-acellular Pertussis Vaccines Absent | Oral Polio Vaccine Absent
Item
children not having received 3 documented doses of dtpahib and polio vaccines during infancy
boolean
C0008059 (UMLS CUI [1])
C0535644 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032375 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Children | Measles-Mumps-Rubella Vaccine Dose
Item
children having received a documented dose of mmr during infancy
boolean
C0008059 (UMLS CUI [1])
C0065828 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES
Item
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1875384 (UMLS CUI [3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
administration of systemic corticosteroids (inhaled and topical steroids are allowed).
boolean
C3653708 (UMLS CUI [1])
Vaccine Except Study Protocol
Item
administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
boolean
C0042210 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Vaccination Previous Hepatitis A
Item
previous vaccination against hepatitis a.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0019159 (UMLS CUI [1,3])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Congenital defects 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])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Vaccine Containing Hepatitis A Antigen
Item
children who had received a hepatitis a antigen containing vaccine since the last visit
boolean
C0042210 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0062523 (UMLS CUI [1,3])
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