ID

29173

Description

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Keywords

Versions (2)
  1. 2/26/18 2/26/18 -
  2. 3/4/18 3/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

English

Visit 1

1 forms  
  1. StudyEvent: ODM
    1. Visit 1
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Center
Description

Center ID

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Other Race, please specify
Description

If you chose 'Other Race', please specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3845569
Eligibility Questions
Description

Eligibility Questions

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

If No, please complete in seperate form

Data type

boolean

Alias
UMLS CUI [1]
C1516637
General Medical History / Physical Examination
Description

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
Description

If "Yes", please check appropriate box(es) and give diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0031809
Specify Medical History
Description

Specify Medical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Diagnosis body system
Description

Diagnosis body system

Data type

integer

Alias
UMLS CUI [1,1]
C0682591
UMLS CUI [1,2]
C0011900
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past or current diagnosis
Description

Past or current diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0521116
Pre-vaccination assessment
Description

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0005903
UMLS CUI-3
C0042196
Temperature
Description

Temperature

Data type

float

Measurement units
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Description

Route of temperature measurement

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Description

only one box must be checked (*) Please comment (**) Please complete additional form

Data type

text

Alias
UMLS CUI [1]
C2368628
Side
Description

Vaccine administration side

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Site
Description

Vaccine administration site

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Route
Description

Vaccine administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Please comment, if vial number wrong or replacement vial has been used.
Description

Vaccine administration comment

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Has the study vaccine been administered according to the Protocol?
Description

Protocol: Side: Right Site: Thigh Route: I.M. If not, fill out below

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
Fill out, if vaccine was not administered
Description

Fill out, if vaccine was not administered

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1272696
Why not administered?
Description

Please tick the ONE most appropriate reason and skip the following forms belonging to this Visit

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
If SAE, please specify SAE N°
Description

Serious Adverse Event form

Data type

integer

Alias
UMLS CUI [1]
C1519255
If AEX, please specify AE N° (Unsol.) or code (Solicited)
Description

Non-Serious adverse event (complete the Non-serious Adverse Event section).

Data type

integer

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

(e.g.: consent withdrawal, Protocol violation,…)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C1272696
Who took the decision?
Description

took decision

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1548562
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Similar models

Visit 1

1 forms
  1. StudyEvent: ODM
    1. Visit 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Center ID
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Others (9)
C0034510 (UMLS CUI-1)
C3845569 (UMLS CUI-2)
(Comment:en)
CL Item
South Asian (6)
C1519427 (UMLS CUI-1)
(Comment:en)
CL Item
East & South East Asian (5)
C0003983 (UMLS CUI-1)
(Comment:en)
CL Item
White/Caucasian (2)
C0043157 (UMLS CUI-1)
(Comment:en)
CL Item
Arabic/North African (4)
C0238604 (UMLS CUI-1)
(Comment:en)
CL Item
Black (1)
C0005680 (UMLS CUI-1)
(Comment:en)
CL Item
American Hispanic (7)
C0019576 (UMLS CUI-1)
(Comment:en)
CL Item
Japanese (8)
C1556094 (UMLS CUI-1)
(Comment:en)
Other Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Eligibility Questions
C1516637 (UMLS CUI-1)
Eligibility Criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
General Medical History / Physical Examination
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ?
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Item Group
Specify Medical History
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Item
Diagnosis body system
integer
C0682591 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis body systems
Code List
Diagnosis body system
CL Item
Genitourinary (12)
C0042066 (UMLS CUI-1)
(Comment:en)
CL Item
Haematology (11)
C0474523 (UMLS CUI-1)
(Comment:en)
CL Item
Endocrine (9)
C0014136 (UMLS CUI-1)
(Comment:en)
CL Item
Neurological (8)
C0746866 (UMLS CUI-1)
(Comment:en)
CL Item
Muskuloskeletal (7)
C0026860 (UMLS CUI-1)
(Comment:en)
CL Item
Allergies (4)
C0020517 (UMLS CUI-1)
(Comment:en)
CL Item
Respiratory (3)
C0035237 (UMLS CUI-1)
(Comment:en)
CL Item
Cardiovascular (2)
C0007226 (UMLS CUI-1)
(Comment:en)
CL Item
Gastrointestinal (1)
C0012240 (UMLS CUI-1)
(Comment:en)
CL Item
Other (specify) (99)
C0460002 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
CL Item
Ears-nose-throat (6)
C0553490 (UMLS CUI-1)
(Comment:en)
CL Item
Eyes (5)
C0015392 (UMLS CUI-1)
(Comment:en)
CL Item
Cutaneus (10)
C1123023 (UMLS CUI-1)
(Comment:en)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or current diagnosis
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Past or current
Code List
Past or current diagnosis
CL Item
current (2)
CL Item
past (1)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route
CL Item
Axillary (A)
C1531924 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal (R)
C0489749 (UMLS CUI-1)
(Comment:en)
CL Item
Tympanic (rectal conversion) (Y)
C1532039 (UMLS CUI-1)
(Comment:en)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
INFANRIX (I)
C1964896 (UMLS CUI-1)
(Comment:en)
CL Item
Replacement vial (*) (R)
C0184301 (UMLS CUI-1)
C0559956 (UMLS CUI-2)
(Comment:en)
CL Item
Wrong vial number (*) (W)
C0184301 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
C3827420 (UMLS CUI-3)
(Comment:en)
CL Item
Not administered (**) (N)
C2368628 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
(Comment:en)
Item
Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration side
Code List
Side
CL Item
Left (L)
C0205091 (UMLS CUI-1)
(Comment:en)
CL Item
Right (R)
C0205090 (UMLS CUI-1)
(Comment:en)
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine administration site
Code List
Site
CL Item
Deltoid (D)
C0224234 (UMLS CUI-1)
(Comment:en)
CL Item
Thigh (T)
C0039866 (UMLS CUI-1)
(Comment:en)
CL Item
Buttock (B)
C0006497 (UMLS CUI-1)
(Comment:en)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration Route
Code List
Route
CL Item
I.M. (I)
C0021492 (UMLS CUI-1)
(Comment:en)
CL Item
S.C. (S)
C0021499 (UMLS CUI-1)
(Comment:en)
Vaccine administration comment
Item
Please comment, if vial number wrong or replacement vial has been used.
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
vaccine administered according to protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item Group
Fill out, if vaccine was not administered
C2368628 (UMLS CUI-1)
C1272696 (UMLS CUI-2)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Reason Vaccine not administered
Code List
Why not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
C1519255 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
C1518404 (UMLS CUI-1)
(Comment:en)
CL Item
Other, please specify (OTH)
C0205394 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C1272696 (UMLS CUI-4)
(Comment:en)
Serious adverse event
Item
If SAE, please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Non-serious adverse event
Item
If AEX, please specify AE N° (Unsol.) or code (Solicited)
integer
C1518404 (UMLS CUI [1])
Other reason for non-administration
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Item
Who took the decision?
text
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
took decision
Code List
Who took the decision?
CL Item
Investigator (I)
C0008961 (UMLS CUI-1)
(Comment:en)
CL Item
Parents/Guardians (P)
C0030551 (UMLS CUI-1)
C0023226 (UMLS CUI-3)
(Comment:en)
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