ID

29173

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 26-02-18 26-02-18 -
  2. 04-03-18 04-03-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 maart 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Infanrix Vaccine - 102038

Engels

Visit 1

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 1
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Center
Beschrijving

Center ID

Datatype

text

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

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Informed consent
Beschrijving

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschrijving

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

Datatype

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Race

Datatype

integer

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

If you chose 'Other Race', please specify

Datatype

text

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

Eligibility Questions

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

If No, please complete in seperate form

Datatype

boolean

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

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 ?
Beschrijving

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

Datatype

boolean

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

Specify Medical History

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

Diagnosis body system

Datatype

integer

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

Diagnosis

Datatype

text

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

Past or current diagnosis

Datatype

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
Beschrijving

Pre-vaccination assessment

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

Temperature

Datatype

float

Maateenheden
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Beschrijving

Route of temperature measurement

Datatype

text

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

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C2368628
Side
Beschrijving

Vaccine administration side

Datatype

text

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

Vaccine administration site

Datatype

text

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

Vaccine administration Route

Datatype

text

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

Vaccine administration comment

Datatype

text

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

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

Datatype

boolean

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

Fill out, if vaccine was not administered

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

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

Datatype

text

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

Serious Adverse Event form

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

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?
Beschrijving

took decision

Datatype

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1548562
Terug naar het begin van de pagina

Similar models

Visit 1

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 1
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial