ID

26498

Beschreibung

A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Biologicals' Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00263679

Stichworte

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  1. 18.10.17 18.10.17 -
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GlaxoSmithKline

Hochgeladen am

18. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Study ID 100406/004 Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster Visit 2

Englisch

GSK Study ID 100406/004 Visit 2

1 Formulare  
Check for Study Continuation
Beschreibung

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Protocol
Beschreibung

Protocol

Datentyp

integer

Alias
UMLS CUI [1]
C1507394
CRF
Beschreibung

Case Report File

Datentyp

text

Alias
UMLS CUI [1]
C1516308
Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Did the subject come at visit 2?
Beschreibung

Did the subject come at visit 2?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Why didn´t the subject return to visit 2?
Beschreibung

Why didn´t the subject return to visit 2?

Datentyp

integer

Alias
UMLS CUI [1]
C2348568
Please specify SAE N°
Beschreibung

Serious adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Please specify AE type
Beschreibung

Non-serious adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Unsol.):
Beschreibung

Non-serious adverse event, unsolicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Solicited)
Beschreibung

Non-serious adverse event, solicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Other, please specify:
Beschreibung

Other events

Datentyp

text

Alias
UMLS CUI [1]
C0441471
Who took the decision:
Beschreibung

Who took the decision

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Pre-vaccination assessment
Beschreibung

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0042196
Length of the upper arm (non-dominant) to be injected:
Beschreibung

Please record the length of the upper arm (non-dominant). Clothing should be removed as to not interfere with the measurement. The upper arm length is defined as the distance between the acromion and the tip of the elbow.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0426866
UMLS CUI [1,2]
C0446516
mm
Circumference of the mid upper arm (non-dominant) to be injected:
Beschreibung

The measurement will be performed at the mid-point of the upper arm (at mid distance between the acromion and the tip of the elbow), while the arm is held parallel to the trunk and the elbow is flexed in front at 90o (as if the subject were carrying a tray). Clothing (e.g., shirt, sweater, blouse) should be removed so as not to interfere with the measurements. The deltoid muscle should not be contracted during the measurement. The mid-point of the upper arm will be marked by study personnel at the time of r measurement and will be used as reference for further measurements done by the subject or subject's parents / guardian during the follow-up period.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1]
C0562351
mm
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • degrees celsius
Alias
UMLS CUI [1]
C0005903
degrees celsius
Temperature, measurement site
Beschreibung

Temperature, measurement site

Datentyp

integer

Alias
UMLS CUI [1]
C0489453
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Blood sample
Beschreibung

Blood sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken?
Beschreibung

Has a blood sample been taken?

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Beschreibung

Please complete only if different from visit date:

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
URINE SAMPLE (Pregnancy test – HCG)
Beschreibung

URINE SAMPLE (Pregnancy test – HCG)

Alias
UMLS CUI-1
C0200354
Has a urine sample been taken?
Beschreibung

Has a urine sample been taken?

Datentyp

integer

Alias
UMLS CUI [1]
C0200354
Date urine sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Vaccine adminstration
Beschreibung

Vaccine adminstration

Alias
UMLS CUI-1
C2368628
Please complete only if different from visit date:
Beschreibung

Date of vaccine administration

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Vaccine administration
Beschreibung

(only one box must be ticked by vaccine) Subjects who received dTpa 0.3 mg at Visit 1 will receive Havrix® at Visit 2 and subjects who receive Havrix® at Visit 1 will receive dTpa 0.3 mg at Visit 2.

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Side / site route
Beschreibung

Non-dominant, upper deltoid, i.m.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the protocol?
Beschreibung

Has the study vaccine been administered according to the protocol?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2599718
Arm:
Beschreibung

Handedness

Datentyp

integer

Alias
UMLS CUI [1]
C0023114
Site:
Beschreibung

Anatomic site

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
Route:
Beschreibung

Drug administration route

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Comments:
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Why not administered?
Beschreibung

Why not administered?

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C1548562
Category for non administration:
Beschreibung

Category for non administration

Datentyp

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please specify SAE N°
Beschreibung

Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Please specify AE type
Beschreibung

Non-serious adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Unsol.):
Beschreibung

Non-serious adverse event, unsolicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Solicited)
Beschreibung

Non-serious adverse event, solicited

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Other, please specify:
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Who took the decision:
Beschreibung

Who took the decision

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1548562
Adverse events - Post - vaccination oberservation
Beschreibung

Adverse events - Post - vaccination oberservation

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0700325
UMLS CUI-3
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Beschreibung

Serious or non-serious unsolicited adverse events after vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0042196
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Ähnliche Modelle

GSK Study ID 100406/004 Visit 2

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Protocol
Item
Protocol
integer
C1507394 (UMLS CUI [1])
Case Report File
Item
CRF
text
C1516308 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Did the subject come at visit 2?
Item
Did the subject come at visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Why didn´t the subject return to visit 2?
integer
C2348568 (UMLS CUI [1])
Why didn´t the subject return to visit 2?
Code List
Why didn´t the subject return to visit 2?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event page) (2)
CL Item
Other (3)
Serious adverse event
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Item
Please specify AE type
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event
Code List
Please specify AE type
CL Item
Unsolicited (1)
CL Item
Solicited (2)
Non-serious adverse event, unsolicited
Item
Please specify AE N° (Unsol.):
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event, solicited
Item
Please specify AE N° (Solicited)
integer
C1518404 (UMLS CUI [1])
Other events
Item
Other, please specify:
text
C0441471 (UMLS CUI [1])
Item
Who took the decision:
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Who took the decision
Code List
Who took the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Baseline measurement of the length of upper arm to be injected
Item
Length of the upper arm (non-dominant) to be injected:
integer
C0426866 (UMLS CUI [1,1])
C0446516 (UMLS CUI [1,2])
Baseline measurement of mid upper arm circumference
Item
Circumference of the mid upper arm (non-dominant) to be injected:
integer
C0562351 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature, measurement site
integer
C0489453 (UMLS CUI [1])
Temperature, measurement site
Code List
Temperature, measurement site
CL Item
Axillary (preferred) (1)
CL Item
Oral (2)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item Group
Blood sample
C0005834 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
URINE SAMPLE (Pregnancy test – HCG)
C0200354 (UMLS CUI-1)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
Has a urine sample been taken?
Code List
Has a urine sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date urine sample taken
Item
Date urine sample taken
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Vaccine adminstration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
Crossover vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Item
Side / site route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Side / site route
Code List
Side / site route
CL Item
Left (1)
CL Item
Right (2)
Has the study vaccine been administered according to the protocol?
Item
Has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2599718 (UMLS CUI [1,2])
Item
Arm:
integer
C0023114 (UMLS CUI [1])
Handedness
Code List
Arm:
CL Item
Dominant (1)
CL Item
Non dominant (2)
CL Item
NA (3)
Item
Site:
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Anatomic Site
Code List
Site:
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route:
integer
C0013153 (UMLS CUI [1])
Drug administration route
Code List
Route:
CL Item
I.m. (1)
CL Item
S.c. (2)
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item Group
Why not administered?
C0042210 (UMLS CUI-1)
C1548562 (UMLS CUI-2)
Item
Category for non administration:
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Category for non administration
Code List
Category for non administration:
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event page) (2)
CL Item
Other (3)
Serious Adverse Event
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Item
Please specify AE type
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event
Code List
Please specify AE type
CL Item
Unsolicited (1)
CL Item
Solicited (2)
Non-serious adverse event, unsolicited
Item
Please specify AE N° (Unsol.):
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event, solicited
Item
Please specify AE N° (Solicited)
integer
C1518404 (UMLS CUI [1])
Other adverse event
Item
Other, please specify:
text
C0877248 (UMLS CUI [1])
Item
Who took the decision:
integer
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
Who took the decision
Code List
Who took the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Adverse events - Post - vaccination oberservation
C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
integer
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Serious or non-serious unsolicited adverse events after vaccination
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not retrievable (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the non-serious adverse event pages or serious adverse event form. (4)
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