ID

29594

Beschrijving

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

Trefwoorden

Versies (1)
  1. 09-04-18 09-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis B NCT00693186

Engels

Eligibility Hepatitis B NCT00693186

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Healthy child | Age

Datatype

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,
Beschrijving

Child Vaccination | Hexavac Dose Quantity | Infanrix hexa Dose Quantity

Datatype

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.
Beschrijving

Informed Consent Parent | Informed Consent Patient Representative

Datatype

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.
Beschrijving

Protocol Compliance Parent | Protocol Compliance Patient Representative

Datatype

boolean

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

Exclusion Criteria

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

Febrile illness prior to Vaccination

Datatype

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,
Beschrijving

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

Datatype

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,
Beschrijving

Communicable Disease Due to Hepatitis B

Datatype

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,
Beschrijving

Contact with Hepatitis B virus carrier

Datatype

boolean

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

Hypersensitivity Study Vaccine Component

Datatype

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,
Beschrijving

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

Datatype

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,
Beschrijving

Thrombocytopenia Severe | Blood Coagulation Disorders | Medical contraindication Intramuscular injection

Datatype

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,
Beschrijving

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

Datatype

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,
Beschrijving

CORTICOSTEROIDS FOR SYSTEMIC USE | Prednisone Equivalent

Datatype

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,
Beschrijving

Immunoglobulins | Blood product

Datatype

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,
Beschrijving

Vaccines, Inactivated

Datatype

boolean

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

Vaccines, Attenuated

Datatype

boolean

Alias
UMLS CUI [1]
C0042211
Terug naar het begin van de pagina

Similar models

Eligibility Hepatitis B NCT00693186

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial