ID

29245

Descripción

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.

Palabras clave

Versiones (1)
  1. 11/3/18 11/3/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de marzo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

Inglés

Additional Forms

1 formularios  
  1. StudyEvent: ODM
    1. Additional Forms
Header
Descripción

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
EXTENSIVE SWELLING REPORT
Descripción

EXTENSIVE SWELLING REPORT

Alias
UMLS CUI-1
C0684224
UMLS CUI-2
C0038999
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
1. Date of physical examination
Descripción

Date of physical examination

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031809
Was the examination performed by a member of study personnel during the extensive swelling period :
Descripción

Research Personnel; physical examination swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035173
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0038999
2. Date when the swelling was first considered to be extensive:
Descripción

Date swelling

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
If occurring within 24 hours after vaccination, please specify how long after vaccination:
Descripción

Swelling; Vaccination

Tipo de datos

text

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2]
C0042196
3. Size of swelling:
Descripción

Measurement of the greatest diameter

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C0456389
mm
4. Type of swelling:
Descripción

Type

Tipo de datos

text

Alias
UMLS CUI [1]
C0332307
5. Circumference of swollen limb (at the site of maximum swelling):
Descripción

Circumference Swelling limb

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0015385
mm
5. Circumference of the opposite limb (at the same level):
Descripción

Circumference limb

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
6. Associated signs: Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Route:
Descripción

Body temperature measurement site

Tipo de datos

integer

Alias
UMLS CUI [1]
C0489453
6. Associated signs: Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Largest diameter :
Descripción

diameter

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1301886
mm
6. Associated signs: Induration
Descripción

Induration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332534
Largest diameter :
Descripción

diameter

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1]
C1301886
mm
6. Associated signs: Pain (at administration site)
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Descripción

Intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518690
6. Associated signs: Functional impairment
Descripción

Functional impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4062321
Intensity
Descripción

Intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518690
7. Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
Descripción

Swelling Description; diagnostic procedure; therapeutic interventions.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0678257
UMLS CUI [2]
C0430022
UMLS CUI [3]
C0808232
8. Last date when the swelling was still considered to be extensive:
Descripción

Last date swelling

Tipo de datos

date

Alias
UMLS CUI [1,1]
C3260033
UMLS CUI [1,2]
C0038999
If lasting for less than 24 hours, please specify duration (hours):
Descripción

Duration Swelling

Tipo de datos

integer

Unidades de medida
  • hours
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0038999
hours
9. Outcome of the swelling:
Descripción

Outcome swelling

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0038999
10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
Descripción

causality allergy infection trauma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0009450
UMLS CUI [1,4]
C3714660
If yes, please specify:
Descripción

Specify

Tipo de datos

text

Alias
UMLS CUI [1]
C1521902
Concomitant Vaccination
Descripción

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
Descripción

Concomitant Vaccination

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant vaccination
Descripción

Concomitant vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Descripción

Trade name of vaccine

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0042196
Administration date
Descripción

Vaccine administration date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Descripción

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Descripción

Medication

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
Medication
Descripción

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Trade or generic name
Descripción

Medication name

Tipo de datos

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Descripción

Indication

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication: Prophylactic?
Descripción

Prophylactic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Total daily dose
Descripción

Total daily dose

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Descripción

Administration Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Descripción

Medication Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Descripción

Medication End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing: tick box if continuing at end of study
Descripción

Medication Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Non-serious Adverse Events
Descripción

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Descripción

(Please report all serious adverse events only on the Serious Adverse Event (SAE) form).

Tipo de datos

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Descripción

Adverse Event Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse events: Description
Descripción

Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-serious adverse events: Description
Descripción

Description

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
Descripción

Start

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
In your opinion, did the vaccine possibly contribute to this AE?
Descripción

Causality

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1518404
Outcome
Descripción

Outcome

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Did the subject seek medical advice?
Descripción

If yes, specify

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1386497
Type - Medical advice
Descripción

Type - Medical advice

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
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Similar models

Additional Forms

1 formularios
  1. StudyEvent: ODM
    1. Additional Forms
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
EXTENSIVE SWELLING REPORT
C0684224 (UMLS CUI-1)
C0038999 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Date of physical examination
Item
1. Date of physical examination
date
C0011008 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Research Personnel; physical examination swelling
Item
Was the examination performed by a member of study personnel during the extensive swelling period :
boolean
C0035173 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0038999 (UMLS CUI [2,2])
Date swelling
Item
2. Date when the swelling was first considered to be extensive:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Swelling; Vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
text
C0038999 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Size
Item
3. Size of swelling:
float
C0456389 (UMLS CUI [1])
Item
4. Type of swelling:
text
C0332307 (UMLS CUI [1])
Type
Code List
4. Type of swelling:
CL Item
Local swelling around injection site, not involving adjacent joint (Local swelling around injection site, not involving adjacent joint)
CL Item
Diffuse swelling, not involving adjacent joint (Diffuse swelling, not involving adjacent joint)
CL Item
Swelling, involving adjacent joint (Swelling, involving adjacent joint)
Circumference Swelling limb
Item
5. Circumference of swollen limb (at the site of maximum swelling):
float
C0424682 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
Circumference limb
Item
5. Circumference of the opposite limb (at the same level):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Temperature
Item
6. Associated signs: Temperature
float
C0039476 (UMLS CUI [1])
Item
Route:
integer
C0489453 (UMLS CUI [1])
body temperature
Code List
Route:
CL Item
Axillary [ A ] (1)
C0004454 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal [ R ] (2)
C0205052 (UMLS CUI-1)
(Comment:en)
Redness
Item
6. Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Induration
Item
6. Associated signs: Induration
boolean
C0332534 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Pain
Item
6. Associated signs: Pain (at administration site)
boolean
C0030193 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
grade 1: Minor reaction to touch (1)
CL Item
grade 2: Cries / protests on touch (2)
CL Item
grade 3: Cries when limb is moved /spontaneously painful (3)
Functional impairment
Item
6. Associated signs: Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
grade 1: easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
grade 2: sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
grade 3: prevents normal everyday activities (3)
Swelling Description; diagnostic procedure; therapeutic interventions.
Item
7. Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
text
C0038999 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2])
C0808232 (UMLS CUI [3])
Last date swelling
Item
8. Last date when the swelling was still considered to be extensive:
date
C3260033 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Duration Swelling
Item
If lasting for less than 24 hours, please specify duration (hours):
integer
C0449238 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Item
9. Outcome of the swelling:
integer
C1705586 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Outcome swelling
Code List
9. Outcome of the swelling:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
causality allergy infection trauma
Item
10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
boolean
C1314792 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C3714660 (UMLS CUI [1,4])
Specify
Item
If yes, please specify:
text
C1521902 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
pharmaceutical preparations
Code List
Has any vaccine other than the study vaccine(s) been administered during the period starting 30 days prior to the vaccine dose and ending one month [minimum 30 days] after it?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade name of vaccine
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Vaccine administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item Group
Medication
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Item
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Causality
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Medical advice
Item
Did the subject seek medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type - Medical advice
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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