ID

35700

Beschrijving

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Trefwoorden

Versies (1)
  1. 16-03-19 16-03-19 -
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GlaxoSmithKline

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16 maart 2019

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Engels

Informed Consent for the long-term follow-up

1 Formulieren  
Informed Consent for the long-term follow-up
Beschrijving

Informed Consent for the long-term follow-up

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C1517942
Subject’s parent or legal guardian’s first name and family name
Beschrijving

I Hereby freely give my consent for my child/ward to take part in this study.

Datatype

text

Alias
UMLS CUI [1,1]
C1443235
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C1301584
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C1443235
UMLS CUI [3,2]
C0085537
UMLS CUI [4,1]
C1301584
UMLS CUI [4,2]
C0085537
Participant's Firs Name, Family Name
Beschrijving

Participant's Firs Name, Family Name

Datatype

text

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1443235
UMLS CUI [2,1]
C0679646
UMLS CUI [2,2]
C1301584
Participant's Signature (where applicable)
Beschrijving

Participant's Signature (where applicable)

Datatype

text

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1519316
Parent/ Guardian's First Name, Family Name
Beschrijving

Parent/ Guardian's First Name, Family Name

Datatype

text

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C1443235
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C1301584
UMLS CUI [3,1]
C0023226
UMLS CUI [3,2]
C1443235
UMLS CUI [4,1]
C0023226
UMLS CUI [4,2]
C1301584
Parent/ Guardian's siganture
Beschrijving

Parent/ Guardian's siganture

Datatype

text

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C1519316
UMLS CUI [2,1]
C0023226
UMLS CUI [2,2]
C1519316
Relationship to participant
Beschrijving

Relationship to participant

Datatype

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0679646
Participant's main address
Beschrijving

Participant's main address

Datatype

text

Alias
UMLS CUI [1]
C0421449
Participant’s phone number:
Beschrijving

Participant’s phone number:

Datatype

integer

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1515258
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
Witness
Beschrijving

Witness

Datatype

text

Alias
UMLS CUI [1]
C0682356
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:
Beschrijving

Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:

Alias
UMLS CUI-1
C1710187
UMLS CUI-2
C0031831
UMLS CUI-3
C0028661
UMLS CUI-4
C1709701
UMLS CUI-5
C0401893
UMLS CUI-6
C0021430
Name
Beschrijving

I have carefully explained the nature, demands and foreseeable risks and benefits of the vaccination study to the person named above and witnessed the completion of the written consent form.

Datatype

text

Alias
UMLS CUI [1]
C0027365
Signature
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
Designation
Beschrijving

Designation

Datatype

text

Alias
UMLS CUI [1]
C0442504
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Informed Consent for the long-term follow-up

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Informed Consent for the long-term follow-up
C0021430 (UMLS CUI-1)
C1517942 (UMLS CUI-2)
Subject’s parent or legal guardian’s first name and family name
Item
Subject’s parent or legal guardian’s first name and family name
text
C1443235 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C1443235 (UMLS CUI [3,1])
C0085537 (UMLS CUI [3,2])
C1301584 (UMLS CUI [4,1])
C0085537 (UMLS CUI [4,2])
Participant's Firs Name, Family Name
Item
Participant's Firs Name, Family Name
text
C0679646 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
C0679646 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
Participant's Signature (where applicable)
Item
Participant's Signature (where applicable)
text
C0679646 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Parent/ Guardian's First Name, Family Name
Item
Parent/ Guardian's First Name, Family Name
text
C0030551 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
C0030551 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
C0023226 (UMLS CUI [3,1])
C1443235 (UMLS CUI [3,2])
C0023226 (UMLS CUI [4,1])
C1301584 (UMLS CUI [4,2])
Parent/ Guardian's siganture
Item
Parent/ Guardian's siganture
text
C0030551 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0023226 (UMLS CUI [2,1])
C1519316 (UMLS CUI [2,2])
Relationship to participant
Item
Relationship to participant
text
C0439849 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
Participant's main address
Item
Participant's main address
text
C0421449 (UMLS CUI [1])
Participant’s phone number:
Item
Participant’s phone number:
integer
C0679646 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Witness
Item
Witness
text
C0682356 (UMLS CUI [1])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Statement by Doctor, Nurse or Project Assistant who conducted the informed consent discussion:
C1710187 (UMLS CUI-1)
C0031831 (UMLS CUI-2)
C0028661 (UMLS CUI-3)
C1709701 (UMLS CUI-4)
C0401893 (UMLS CUI-5)
C0021430 (UMLS CUI-6)
Name
Item
Name
text
C0027365 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Designation
Item
Designation
text
C0442504 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Terug naar het begin van de pagina 

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