ID

25025

Description

Visit 4 Dose 2 Local Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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. 8/24/17 8/24/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 4 Dose 2 Local Symptoms Biologicals HepA/HepB vaccine 208127/125

English

Visit 4 Dose 2 Local Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Activity
Description

Activity

Data type

text

Alias
UMLS CUI [1]
C1512346
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
SOLICITED ADVERSE EXPERIENCES
Description

SOLICITED ADVERSE EXPERIENCES

Alias
UMLS CUI-1
C1691781
The Diary Card has been returned and all signs and symptoms experienced by the subject are reported on the Diary Card.
Description

I. Please tick how you have obtained complete information on reactogenicity from the subject :

Data type

boolean

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C3176968
The Diary Card has been returned. Additional experiences other than those reported on the Diary Card have been obtained at the time of a contact.
Description

I. Please tick how you have obtained complete information on reactogenicity from the subject :

Data type

boolean

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0205257
UMLS CUI [1,4]
C0037088
The Diary Card has not been returned and reported experiences have been obtained at the time of a contact
Description

I. Please tick how you have obtained complete information on reactogenicity from the subject :

Data type

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C3828769
UMLS CUI [1,3]
C3812666
UMLS CUI [1,4]
C1457887
LOCAL SYMPTOMS
Description

LOCAL SYMPTOMS

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
II. Has the subject experienced any local solicited signs or symptoms since vaccine administration ?
Description

if No: Please, go to paragraph III. if Yes: Please tick a No/Yes box for each symptom. If any experience was observed, please fill in the complete line.

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2368628
Redness
Description

Redness

Alias
UMLS CUI-1
C0332575
Local symptoms (at the injection site)
Description

Local symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
Size Day 0
Description

Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C2826301
mm
Size Day 1
Description

Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C1442449
mm
Size Day 2
Description

Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842676
mm
Size Day 3
Description

Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842675
mm
Corrective therapy ?
Description

Corrective therapy: if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

integer

Alias
UMLS CUI [1]
C1705586
Swelling
Description

Swelling

Alias
UMLS CUI-1
C0038999
Local symptoms (at the injection site)
Description

Local symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
Size Day 0
Description

Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C2826301
mm
Size Day 1
Description

Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C1442449
mm
Size Day 2
Description

Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842676
mm
Size Day 3
Description

Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842675
mm
Corrective therapy ?
Description

Corrective therapy: if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

integer

Alias
UMLS CUI [1]
C1705586
Soreness
Description

Soreness

Alias
UMLS CUI-1
C0030193
Local symptoms (at the injection site)
Description

Local symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Corrective therapy ?
Description

Corrective therapy: if Yes, record in the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Outcome
Description

0utcome : if still ongoing at the end of day 3, please record experience in the Adverse Experience Section

Data type

integer

Alias
UMLS CUI [1]
C1705586
Seriousness of symptoms
Description

Seriousness of symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0871902
Do you consider any of these adverse experiences to be serious ?
Description

if Yes: Please report experience to SmithKline Beecham monitor by telephone, telex or telefax within 24 hours (see protocol) and complete the SAEF form.

Data type

boolean

Alias
UMLS CUI [1]
C1710056
III. OTHER LOCAL SYMPTOMS
Description

III. OTHER LOCAL SYMPTOMS

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
If any local symptom other than those listed above occurred, please complete the Adverse Experience Section.
Description

Complete Adverse Experience Section

Data type

text

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C1521800
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Visit 4 Dose 2 Local Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
SOLICITED ADVERSE EXPERIENCES
C1691781 (UMLS CUI-1)
Diary Card completed and returned
Item
The Diary Card has been returned and all signs and symptoms experienced by the subject are reported on the Diary Card.
boolean
C0332156 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C3176968 (UMLS CUI [1,3])
Incomplete Diary Card returned
Item
The Diary Card has been returned. Additional experiences other than those reported on the Diary Card have been obtained at the time of a contact.
boolean
C0332156 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C0037088 (UMLS CUI [1,4])
Diary Card not returned
Item
The Diary Card has not been returned and reported experiences have been obtained at the time of a contact
boolean
C3890583 (UMLS CUI [1,1])
C3828769 (UMLS CUI [1,2])
C3812666 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item Group
LOCAL SYMPTOMS
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Local solicited signs or symptoms
Item
II. Has the subject experienced any local solicited signs or symptoms since vaccine administration ?
boolean
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item Group
Redness
C0332575 (UMLS CUI-1)
Local symptoms
Item
Local symptoms (at the injection site)
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Day 0
Item
Size Day 0
integer
C0456389 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Size Day 1
Item
Size Day 1
integer
C0456389 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Size Day 2
Item
Size Day 2
integer
C0456389 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Size Day 3
Item
Size Day 3
integer
C0456389 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Swelling
C0038999 (UMLS CUI-1)
Local symptoms
Item
Local symptoms (at the injection site)
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Day 0
Item
Size Day 0
integer
C0456389 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Size Day 1
Item
Size Day 1
integer
C0456389 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Size Day 2
Item
Size Day 2
integer
C0456389 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Size Day 3
Item
Size Day 3
integer
C0456389 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Soreness
C0030193 (UMLS CUI-1)
Local symptoms
Item
Local symptoms (at the injection site)
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 1
Code List
Intensity Day 1
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 2
Code List
Intensity Day 2
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Corrective therapy
Item
Corrective therapy ?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Seriousness of symptoms
C1457887 (UMLS CUI-1)
C0871902 (UMLS CUI-2)
Seriousness of symptoms
Item
Do you consider any of these adverse experiences to be serious ?
boolean
C1710056 (UMLS CUI [1])
Item Group
III. OTHER LOCAL SYMPTOMS
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Complete Adverse Experience Section
Item
If any local symptom other than those listed above occurred, please complete the Adverse Experience Section.
text
C0205197 (UMLS CUI [1,1])
C1521800 (UMLS CUI [1,2])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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