ID

35700

Description

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

Keywords

Versions (1)
  1. 3/16/19 3/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 16, 2019

DOI

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License

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)

English

Informed Consent for the long-term follow-up

1 forms  
Informed Consent for the long-term follow-up
Description

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
Description

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

Data type

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
Description

Participant's Firs Name, Family Name

Data type

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)
Description

Participant's Signature (where applicable)

Data type

text

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

Parent/ Guardian's First Name, Family Name

Data type

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
Description

Parent/ Guardian's siganture

Data type

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
Description

Relationship to participant

Data type

text

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

Participant's main address

Data type

text

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

Participant’s phone number:

Data type

integer

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Witness
Description

Witness

Data type

text

Alias
UMLS CUI [1]
C0682356
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

integer

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

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
Description

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.

Data type

text

Alias
UMLS CUI [1]
C0027365
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Designation
Description

Designation

Data type

text

Alias
UMLS CUI [1]
C0442504
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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Similar models

Informed Consent for the long-term follow-up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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