ID

34737

Beschrijving

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about eligibility criteria and should be filled in at visit 1 (month 0, pre-vacc).

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Trefwoorden

Versies (1)
  1. 25-01-19 25-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

Engels

Eligibility criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Eligibility check
Beschrijving

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all entry criteria?
Beschrijving

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study
Beschrijving

Compliance with protocol requirements

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1274041
A female between, and including, 10 and 14 years of age at the time of the first vaccination.
Beschrijving

Female 10-14 years of age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject
Beschrijving

Written informed assent from subject and informed consent from parent or guardian

Datatype

boolean

Alias
UMLS CUI [1,1]
C1879749
UMLS CUI [1,2]
C0008059
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
Free of obvious health problems as established by medical history and clinical examination before entering into the study
Beschrijving

Free of obvious health problems

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871764
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0871764
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C1456356
Subjects must have a negative urine pregnancy test
Beschrijving

Negative urine pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
Subjects of childbearing potential at the time of study entry must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using an effective method of birth control (i.e. intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, progestogen-only implantable cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
Beschrijving

Abstinence or method of birth control

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion criteria
Beschrijving

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) within 30 days preceding the first dose of study/control vaccine, or planned use during the study period
Beschrijving

Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0205394
UMLS CUI [3,4]
C0332185
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C1517586
UMLS CUI [4,3]
C0205394
UMLS CUI [4,4]
C1301732
Pregnant or breastfeeding
Beschrijving

Pregnant or breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Planning to become pregnant or likely to become pregnant (as determined by the investigator)
Beschrijving

Planning or likely to become pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750492
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs with six months prior to the first vaccine dose.
Beschrijving

For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0205191
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before (Day -30 to Day -1) and 30 days after (i.e. Days 0-29) the first dose of vaccine.
Beschrijving

Administration of routine meningococcal, hepatitis B, inactivated influenza, diphteria/tetanus and/or diphteria/tetanus-containing vaccine up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0940824
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0940824
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0042196
UMLS CUI [3,2]
C0205547
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0042196
UMLS CUI [4,2]
C0205547
UMLS CUI [4,3]
C1301732
UMLS CUI [5]
C0700144
UMLS CUI [6]
C2240392
UMLS CUI [7]
C0021403
UMLS CUI [8]
C0058773
Previous administration of MPL or AS04 adjuvant (no vaccines currently licensed in Korea contain these)
Beschrijving

Previous administration of MPL or AS04 adjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1519886
UMLS CUI [1,3]
C0066776
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C1706672
Previous vaccination against HPV
Beschrijving

Previous vaccination against HPV

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1512511
UMLS CUI [1,3]
C0205156
History of vaccination against hepatitis A or a known clinical history of hepatitis A infection
Beschrijving

History of vaccination against hepatitis A or clinical history of hepatitis A

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0170300
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019159
Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Beschrijving

Immunodeficient condition

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0332147
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0332147
UMLS CUI [4,3]
C0031809
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/ control vaccines, e.g. aluminium, MPL®, hepatitis A antigen, 2-phenoxyethanol or neomycin
Beschrijving

History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/ control vaccines

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1517586
UMLS CUI [1,4]
C1705248
UMLS CUI [1,5]
C0262926
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C1517586
UMLS CUI [2,4]
C1705248
UMLS CUI [2,5]
C0750491
UMLS CUI [3]
C0002367
UMLS CUI [4,1]
C1519886
UMLS CUI [4,2]
C0066776
UMLS CUI [5]
C0062523
UMLS CUI [6]
C0301042
UMLS CUI [7]
C0027603
Hypersensitivity to latex
Beschrijving

(found in syringe-tip cap and plunger)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0023115
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests
Beschrijving

Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0001314
UMLS CUI [1,4]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0001314
UMLS CUI [2,4]
C0022885
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2985739
UMLS CUI [3,3]
C0008679
UMLS CUI [3,4]
C0031809
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C2985739
UMLS CUI [4,3]
C0008679
UMLS CUI [4,4]
C0022885
UMLS CUI [5,1]
C0205494
UMLS CUI [5,2]
C1704258
UMLS CUI [6,1]
C0232741
UMLS CUI [6,2]
C1704258
UMLS CUI [7,1]
C0232804
UMLS CUI [7,2]
C1704258
History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease
Beschrijving

History of chronic condition(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0341439
UMLS CUI [4]
C1561643
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0004364
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
Beschrijving

Enrolment will be deferred until the subject is outside of specified window

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1301732
Acute disease at the time of enrolment.
Beschrijving

Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature < 37.5 °C (99.5 °F)/axillary temperature < 37.5 °C (99.5 °F).

Datatype

boolean

Alias
UMLS CUI [1]
C0001314
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Similar models

Eligibility criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
Did the subject meet all entry criteria?
Item
Did the subject meet all entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Compliance with protocol requirements
Item
Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Female 10-14 years of age
Item
A female between, and including, 10 and 14 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Written informed assent from subject and informed consent from parent or guardian
Item
Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject
boolean
C1879749 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Free of obvious health problems
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
C0871764 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0871764 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
Negative urine pregnancy test
Item
Subjects must have a negative urine pregnancy test
boolean
C0427780 (UMLS CUI [1])
Abstinence or method of birth control
Item
Subjects of childbearing potential at the time of study entry must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using an effective method of birth control (i.e. intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, progestogen-only implantable cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) within 30 days preceding the first dose of study/control vaccine, or planned use during the study period
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
C0042210 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
C1301732 (UMLS CUI [4,4])
Pregnant or breastfeeding
Item
Pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Planning or likely to become pregnant
Item
Planning to become pregnant or likely to become pregnant (as determined by the investigator)
boolean
C0032992 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs with six months prior to the first vaccine dose.
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Planned administration/administration of a vaccine not foreseen by the study protocol
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before (Day -30 to Day -1) and 30 days after (i.e. Days 0-29) the first dose of vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C0940824 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C0940824 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0042196 (UMLS CUI [3,1])
C0205547 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0042196 (UMLS CUI [4,1])
C0205547 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C0700144 (UMLS CUI [5])
C2240392 (UMLS CUI [6])
C0021403 (UMLS CUI [7])
C0058773 (UMLS CUI [8])
Previous administration of MPL or AS04 adjuvant
Item
Previous administration of MPL or AS04 adjuvant (no vaccines currently licensed in Korea contain these)
boolean
C0205156 (UMLS CUI [1,1])
C1519886 (UMLS CUI [1,2])
C0066776 (UMLS CUI [1,3])
C0205156 (UMLS CUI [2,1])
C1706672 (UMLS CUI [2,2])
Previous vaccination against HPV
Item
Previous vaccination against HPV
boolean
C0042196 (UMLS CUI [1,1])
C1512511 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
History of vaccination against hepatitis A or clinical history of hepatitis A
Item
History of vaccination against hepatitis A or a known clinical history of hepatitis A infection
boolean
C0262926 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019159 (UMLS CUI [2,2])
Immunodeficient condition
Item
Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0021051 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0332147 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/ control vaccines
Item
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/ control vaccines, e.g. aluminium, MPL®, hepatitis A antigen, 2-phenoxyethanol or neomycin
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
C0750491 (UMLS CUI [2,5])
C0002367 (UMLS CUI [3])
C1519886 (UMLS CUI [4,1])
C0066776 (UMLS CUI [4,2])
C0062523 (UMLS CUI [5])
C0301042 (UMLS CUI [6])
C0027603 (UMLS CUI [7])
Hypersensitivity to latex
Item
Hypersensitivity to latex
boolean
C0020517 (UMLS CUI [1,1])
C0023115 (UMLS CUI [1,2])
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality
Item
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0001314 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0001314 (UMLS CUI [2,3])
C0022885 (UMLS CUI [2,4])
C1704258 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C0008679 (UMLS CUI [3,3])
C0031809 (UMLS CUI [3,4])
C1704258 (UMLS CUI [4,1])
C2985739 (UMLS CUI [4,2])
C0008679 (UMLS CUI [4,3])
C0022885 (UMLS CUI [4,4])
C0205494 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C0232741 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C0232804 (UMLS CUI [7,1])
C1704258 (UMLS CUI [7,2])
History of chronic condition(s)
Item
History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease
boolean
C0262926 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
C0341439 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
Administration of immunoglobulins and/or any blood product
Item
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0456388 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Acute disease at the time of enrolment.
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
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