ID

22008

Descripción

Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00313950

Link

https://clinicaltrials.gov/show/NCT00313950

Palabras clave

Versiones (1)
  1. 14/5/17 14/5/17 -
Subido en

14 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Measles NCT00313950

Inglés

Eligibility Measles NCT00313950

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Measles NCT00313950
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 12-13 months on the day of inclusion
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
Descripción

pregnancy duration, birth weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0460089
UMLS CUI [2]
C0005612
informed consent form signed by the parent(s) or other legal representative
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
able to attend all scheduled visits and to comply with all trial procedures
Descripción

trial procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2700391
subjects having received only one or no injection of vaccine against measles
Descripción

measles vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025010
subjects anti-hav seronegative according to the results obtained at the screening visit*
Descripción

hav antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0062524
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
Descripción

clinical trial participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
planned participation in another clinical trial during the present trial period
Descripción

clinical trial participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Descripción

immunodeficiency, immunosuppression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0021079
systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
Descripción

vaccine hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0020517
chronic illness at a stage that could interfere with trial conduct or completion
Descripción

chronic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008679
blood or blood-derived products received in the past 3 months
Descripción

blood products

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0456388
any vaccination in the 4 weeks preceding the first trial vaccination
Descripción

vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042196
vaccination planned in the 4 weeks following any trial vaccination
Descripción

vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042196
history of hepatitis a, mumps, measles and/or rubella infection (confirmed either clinically, serologically or microbiologically)
Descripción

hepatitis a, mumps, measles, rubella infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0026780
UMLS CUI [3]
C0025007
UMLS CUI [4]
C0035920
previous vaccination against hepatitis a with the trial vaccine or another vaccine
Descripción

hepatitis a vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0419735
previous vaccination against mumps, measles and rubella with a mumps, measles and rubella trivalent combined vaccine
Descripción

mumps measles rubella trivalent combined vaccination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0199810
thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
Descripción

thrombocytopenia, bleeding disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0005779
history of seizures
Descripción

seizures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
febrile illness (axillary temperature ≥37.4°c]) on the day of inclusion
Descripción

febrile illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743841
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Similar models

Eligibility Measles NCT00313950

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Measles NCT00313950
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
aged 12-13 months on the day of inclusion
boolean
C0001779 (UMLS CUI [1])
pregnancy duration, birth weight
Item
born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
boolean
C0460089 (UMLS CUI [1])
C0005612 (UMLS CUI [2])
informed consent
Item
informed consent form signed by the parent(s) or other legal representative
boolean
C0021430 (UMLS CUI [1])
trial procedures
Item
able to attend all scheduled visits and to comply with all trial procedures
boolean
C0008976 (UMLS CUI [1,1])
C2700391 (UMLS CUI [1,2])
measles vaccine
Item
subjects having received only one or no injection of vaccine against measles
boolean
C0025010 (UMLS CUI [1])
hav antibodies
Item
subjects anti-hav seronegative according to the results obtained at the screening visit*
boolean
C0062524 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
clinical trial participation
Item
participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
boolean
C2348568 (UMLS CUI [1])
clinical trial participation
Item
planned participation in another clinical trial during the present trial period
boolean
C2348568 (UMLS CUI [1])
immunodeficiency, immunosuppression
Item
congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
boolean
C0021051 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
vaccine hypersensitivity
Item
systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
boolean
C0042210 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
chronic disease
Item
chronic illness at a stage that could interfere with trial conduct or completion
boolean
C0008679 (UMLS CUI [1])
blood products
Item
blood or blood-derived products received in the past 3 months
boolean
C0456388 (UMLS CUI [1])
vaccination
Item
any vaccination in the 4 weeks preceding the first trial vaccination
boolean
C0042196 (UMLS CUI [1])
vaccination
Item
vaccination planned in the 4 weeks following any trial vaccination
boolean
C0042196 (UMLS CUI [1])
hepatitis a, mumps, measles, rubella infection
Item
history of hepatitis a, mumps, measles and/or rubella infection (confirmed either clinically, serologically or microbiologically)
boolean
C0019159 (UMLS CUI [1])
C0026780 (UMLS CUI [2])
C0025007 (UMLS CUI [3])
C0035920 (UMLS CUI [4])
hepatitis a vaccination
Item
previous vaccination against hepatitis a with the trial vaccine or another vaccine
boolean
C0419735 (UMLS CUI [1])
mumps measles rubella trivalent combined vaccination
Item
previous vaccination against mumps, measles and rubella with a mumps, measles and rubella trivalent combined vaccine
boolean
C0199810 (UMLS CUI [1])
thrombocytopenia, bleeding disorder
Item
thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
boolean
C0040034 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
seizures
Item
history of seizures
boolean
C0036572 (UMLS CUI [1])
febrile illness
Item
febrile illness (axillary temperature ≥37.4°c]) on the day of inclusion
boolean
C0743841 (UMLS CUI [1])
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