ID

29594

Beschreibung

A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA; ODM derived from: https://clinicaltrials.gov/show/NCT00693186

Link

https://clinicaltrials.gov/show/NCT00693186

Stichworte

Versionen (1)
  1. 09.04.18 09.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. April 2018

DOI

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Eligibility Hepatitis B NCT00693186

Englisch

Eligibility Hepatitis B NCT00693186

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy child of 4 to 7 years of age of either gender,
Beschreibung

Healthy child | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0686744
UMLS CUI [2]
C0001779
child vaccinated with 2 doses of hexavac® during the first 6 months of life and with a 3rd dose of hexavac® before the end of the second year of life or child vaccinated with 2 doses of infanrix®-hexa during the first 6 months of life and with a 3rd dose of infanrix®-hexa before the end of the second year of life,
Beschreibung

Child Vaccination | Hexavac Dose Quantity | Infanrix hexa Dose Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C0972337
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C3661302
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
informed consent form signed by the parent(s) or by the legal representative.
Beschreibung

Informed Consent Parent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
parent(s) or legal representative able to understand and comply with the study procedures.
Beschreibung

Protocol Compliance Parent | Protocol Compliance Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any recent (<=3 days) history of febrile illness prior to vaccination,
Beschreibung

Febrile illness prior to Vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743841
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0042196
receipt of more than 3 doses of any hepatitis b containing vaccine, either alone or in any combination,
Beschreibung

Hepatitis B Vaccine Dose Quantity | Hepatitis B Vaccines Combination Dose Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1265611
history of clinical or serological-confirmed diagnosis of infection due to hepatitis b,
Beschreibung

Communicable Disease Due to Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019163
history or current close contact with known carriers of hepatitis b virus,
Beschreibung

Contact with Hepatitis B virus carrier

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C2025297
prior known sensitivity/allergy to any component of the study vaccines,
Beschreibung

Hypersensitivity Study Vaccine Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C1705248
any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
Beschreibung

Hematological Disease Type Any | Leukemia Type Any | Lymphoma Type Any | Malignant Neoplasms Affecting Hematopoietic System | Malignant Neoplasms Affecting Lymphatic System

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0023418
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C1552551
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0018957
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0024235
any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
Beschreibung

Thrombocytopenia Severe | Blood Coagulation Disorders | Medical contraindication Intramuscular injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0021492
any immune impairment or humoral/cellular deficiency or depressed immunity,
Beschreibung

Impairment immunologic | Deficiency Humoral Immunity | Deficiency Cellular Immunity | Immunity Suppressed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221099
UMLS CUI [1,2]
C0205470
UMLS CUI [2,1]
C0011155
UMLS CUI [2,2]
C0020967
UMLS CUI [3,1]
C0011155
UMLS CUI [3,2]
C0020966
UMLS CUI [4,1]
C0020964
UMLS CUI [4,2]
C1260953
any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through visit 2,
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE | Prednisone Equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through visit 2,
Beschreibung

Immunoglobulins | Blood product

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through visit 2,
Beschreibung

Vaccines, Inactivated

Datentyp

boolean

Alias
UMLS CUI [1]
C0042212
any recent (<=28 days) receipt of a live vaccine or scheduled administration through visit 2
Beschreibung

Vaccines, Attenuated

Datentyp

boolean

Alias
UMLS CUI [1]
C0042211
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Ähnliche Modelle

Eligibility Hepatitis B NCT00693186

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy child | Age
Item
healthy child of 4 to 7 years of age of either gender,
boolean
C0686744 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Child Vaccination | Hexavac Dose Quantity | Infanrix hexa Dose Quantity
Item
child vaccinated with 2 doses of hexavac® during the first 6 months of life and with a 3rd dose of hexavac® before the end of the second year of life or child vaccinated with 2 doses of infanrix®-hexa during the first 6 months of life and with a 3rd dose of infanrix®-hexa before the end of the second year of life,
boolean
C0008059 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0972337 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3661302 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Informed Consent Parent | Informed Consent Patient Representative
Item
informed consent form signed by the parent(s) or by the legal representative.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance Parent | Protocol Compliance Patient Representative
Item
parent(s) or legal representative able to understand and comply with the study procedures.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Febrile illness prior to Vaccination
Item
any recent (<=3 days) history of febrile illness prior to vaccination,
boolean
C0743841 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Hepatitis B Vaccine Dose Quantity | Hepatitis B Vaccines Combination Dose Quantity
Item
receipt of more than 3 doses of any hepatitis b containing vaccine, either alone or in any combination,
boolean
C2240392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2240392 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Communicable Disease Due to Hepatitis B
Item
history of clinical or serological-confirmed diagnosis of infection due to hepatitis b,
boolean
C0009450 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
Contact with Hepatitis B virus carrier
Item
history or current close contact with known carriers of hepatitis b virus,
boolean
C0332158 (UMLS CUI [1,1])
C2025297 (UMLS CUI [1,2])
Hypersensitivity Study Vaccine Component
Item
prior known sensitivity/allergy to any component of the study vaccines,
boolean
C0020517 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
Hematological Disease Type Any | Leukemia Type Any | Lymphoma Type Any | Malignant Neoplasms Affecting Hematopoietic System | Malignant Neoplasms Affecting Lymphatic System
Item
any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
boolean
C0018939 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0023418 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0024299 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0018957 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0024235 (UMLS CUI [5,3])
Thrombocytopenia Severe | Blood Coagulation Disorders | Medical contraindication Intramuscular injection
Item
any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
boolean
C0040034 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0021492 (UMLS CUI [3,2])
Impairment immunologic | Deficiency Humoral Immunity | Deficiency Cellular Immunity | Immunity Suppressed
Item
any immune impairment or humoral/cellular deficiency or depressed immunity,
boolean
C0221099 (UMLS CUI [1,1])
C0205470 (UMLS CUI [1,2])
C0011155 (UMLS CUI [2,1])
C0020967 (UMLS CUI [2,2])
C0011155 (UMLS CUI [3,1])
C0020966 (UMLS CUI [3,2])
C0020964 (UMLS CUI [4,1])
C1260953 (UMLS CUI [4,2])
CORTICOSTEROIDS FOR SYSTEMIC USE | Prednisone Equivalent
Item
any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through visit 2,
boolean
C3653708 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Immunoglobulins | Blood product
Item
any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through visit 2,
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Vaccines, Inactivated
Item
any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through visit 2,
boolean
C0042212 (UMLS CUI [1])
Vaccines, Attenuated
Item
any recent (<=28 days) receipt of a live vaccine or scheduled administration through visit 2
boolean
C0042211 (UMLS CUI [1])
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