ID

35779

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. 3/22/19 3/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 22, 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

Visit 15 (one month post vaccination) - Check for Study Continuation; Laboratory Tests

1 forms  
Check for Study Continuation
Description

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for follow-up concerning the additional vaccination visit?
Description

Yes → Please complete the next pages. No → Please complete below.

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332156
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0940824
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

Please tick the ONE most appropriate reason and skip the following pages of this visit.

Data type

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0392360
If SAE, please specify SAE No
Description

If SAE, please specify SAE No

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
Description

If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If other reason, please specify
Description

If other reason, please specify

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Please tick, who took the decision
Description

Please tick, who took the decision

Data type

text

Alias
UMLS CUI [1]
C0679006
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Has a blood sample been taken?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of blood sample been taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
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Similar models

Visit 15 (one month post vaccination) - Check for Study Continuation; Laboratory Tests

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Did the subject return for follow-up concerning the additional vaccination visit?
Item
Did the subject return for follow-up concerning the additional vaccination visit?
boolean
C1522577 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0940824 (UMLS CUI [2,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C1522577 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form)  (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section)  (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation, …) (OTH)
If SAE, please specify SAE No
Item
If SAE, please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
Item
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Please tick, who took the decision
text
C0679006 (UMLS CUI [1])
Please tick, who took the decision
Code List
Please tick, who took the decision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of blood sample been taken
Item
Date of blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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