ID

24488

Description

Visit 2 Vaccine Administration 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 (3)
  1. 8/1/17 8/1/17 -
  2. 8/2/17 8/2/17 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 2 Vaccine Administration Biologicals HepA/HepB vaccine 208127/125

English

Visit 2 Vaccine Administration 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
VACCINE ADMINISTRATION
Description

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Temperature :
Description

As specified in the protocol, the temperature of the subject should be taken by the oral route.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Axillary route
Description

Axillary temperature

Data type

boolean

Alias
UMLS CUI [1]
C1531924
Oral route
Description

Oral temperature

Data type

boolean

Alias
UMLS CUI [1]
C1532216
Rectal route
Description

Rectal temperature

Data type

boolean

Alias
UMLS CUI [1]
C0489749
Has the study vaccine been administered ?
Description

If Yes, complete the table below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0008972
Please specify and go to next page :
Description

Study vaccine has not been administered

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0008972
HAB
Description

Vaccine

Data type

text

Alias
UMLS CUI [1]
C0593947
Site/Route of injection: Deltoid I.M.
Description

Please specify side :

Data type

text

Alias
UMLS CUI [1]
C2700396
Date administered (day month year)
Description

Date administered

Data type

date

Alias
UMLS CUI [1]
C0011008
Time (24 hr. clock)
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Has the study vaccine been administered according to the protocol ?
Description

Vaccine protocol

Data type

boolean

Alias
UMLS CUI [1]
C2368628
UMLS CUI [2]
C1507394
Injection site :
Description

study vaccine has not been administered according to the protocol

Data type

text

Alias
UMLS CUI [1]
C2700396
Route :
Description

study vaccine has not been administered according to the protocol

Data type

text

Alias
UMLS CUI [1]
C1828121
POST VACCINATION OBSERVATION
Description

POST VACCINATION OBSERVATION

Alias
UMLS CUI-1
C1443955
UMLS CUI-2
C0700325
Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
Description

If Yes, please fill in the Adverse Experience Section and detail the exact time of onset.

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0151862
Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
Description

If Yes, please complete the Medication Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0420172
UMLS CUI [1,2]
C0413534
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Similar models

Visit 2 Vaccine Administration 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
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
Temperature
Item
Temperature :
float
C0005903 (UMLS CUI [1])
Axillary temperature
Item
Axillary route
boolean
C1531924 (UMLS CUI [1])
Oral temperature
Item
Oral route
boolean
C1532216 (UMLS CUI [1])
Rectal temperature
Item
Rectal route
boolean
C0489749 (UMLS CUI [1])
Study vaccine administered
Item
Has the study vaccine been administered ?
boolean
C0042210 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Study vaccine not administered
Item
Please specify and go to next page :
text
C0042210 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item
HAB
text
C0593947 (UMLS CUI [1])
Vaccine
Code List
HAB
CL Item
HAB (HAB)
Item
Site/Route of injection: Deltoid I.M.
text
C2700396 (UMLS CUI [1])
Site/Route of injection
Code List
Site/Route of injection: Deltoid I.M.
CL Item
left (left)
CL Item
right (right)
Date administered
Item
Date administered (day month year)
date
C0011008 (UMLS CUI [1])
Time
Item
Time (24 hr. clock)
time
C0040223 (UMLS CUI [1])
Vaccine protocol
Item
Has the study vaccine been administered according to the protocol ?
boolean
C2368628 (UMLS CUI [1])
C1507394 (UMLS CUI [2])
Injection site
Item
Injection site :
text
C2700396 (UMLS CUI [1])
Route
Item
Route :
text
C1828121 (UMLS CUI [1])
Item Group
POST VACCINATION OBSERVATION
C1443955 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
Adverse experience after vaccination
Item
Has any adverse experience occurred during the immediate 30 minute post vaccination observation period ?
boolean
C0877248 (UMLS CUI [1,1])
C0151862 (UMLS CUI [1,2])
Prophylactic medication
Item
Has any prophylactic medication been administered in anticipation of study vaccine reactions ?
boolean
C0420172 (UMLS CUI [1,1])
C0413534 (UMLS CUI [1,2])
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