ID

32176

Beschreibung

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on https://clinicaltrials.gov/ct2/show/NCT00466947 Clinicaltrials.gov Identifier: NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the check for study continuation and elimination criteria which has to be filled in for Visit 2-9. It also contains physical examination which has to be filled in for Visit 2-4, 6, 9. It's for all workbooks. The document also contains the informed consent form for "all subjects and carriage subset". This item is only for workbook 2 and has to be filled in only for visit 6.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Stichworte

Versionen (3)
  1. 22.10.18 22.10.18 -
  2. 23.10.18 23.10.18 -
  3. 26.10.18 26.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media 109563, NCT00466947

Englisch

Check for continuation, elimination criteria, physical examination

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit number
Beschreibung

Visit number

Datentyp

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
CHECK FOR STUDY CONTINUATION
Beschreibung

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit?
Beschreibung

If subject return to visit please complete the next pages

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
No return to visit
Beschreibung

Please tick the ONE most appropriate reason and skip the following pages of this visit. If there is a SAE please complete and submit SAE report. If there is a AEX please complete Non-serious Adverse Event section. If there is an other reason for no return please specify in following item.

Datentyp

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0805733
UMLS CUI [1,4]
C0566251
If SAE Number
Beschreibung

Please complete and submit SAE report

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If AE Number please specify
Beschreibung

Please complete Non-serious Adverse Event section

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If solicited AE Code
Beschreibung

In workbook 1 and 2 only for immuno and reato subset.

Datentyp

text

Alias
UMLS CUI [1,1]
C0683368
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C1518404
UMLS CUI [1,4]
C0805701
If other reason for no return
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
who made the decision
Beschreibung

Decision made by Investigator, Parents/Guardians

Datentyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0008961
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0030551
UMLS CUI [2,3]
C0023226
ELIMINATION CRITERIA
Beschreibung

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable since last visit?
Beschreibung

Please tick all that applies in following items. Note: Please check exclusion criteria for further participation (only if subject returns at the visit)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
Same reason and decision as previous visit.
Beschreibung

For Visit 3-9

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0445247
UMLS CUI [1,3]
C0205156
UMLS CUI [1,4]
C0545082
Chronic administration of immunosuppressants or other immune-modifying drugs.
Beschreibung

Chronic administration is defined as more than 14 days

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0005525
Major congenital defects or serious chronic illness.
Beschreibung

Elimination criteria: Major congenital defects/serious chronic illness.

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0220810
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0205404
Any confirmed or suspected immunosuppressive or immunodeficient condition.
Beschreibung

Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C3829792
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C4048329
UMLS CUI [4,1]
C0242114
UMLS CUI [4,2]
C3829792
UMLS CUI [5,1]
C0242114
UMLS CUI [5,2]
C4048329
Administration of immunoglobulins and/or any blood derived products.
Beschreibung

Elimination criteria: immunoglobulins/any blood derived products

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0021027
UMLS CUI [3]
C0456388
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
Beschreibung

Elimination criteria: use of investigational or non-registered product

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C2348563
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ADDITIONAL IMMUNO ICF
Beschreibung

ADDITIONAL IMMUNO ICF

Alias
UMLS CUI-1
C0021430
Did the parents/guardians sign the additional immuno ICF?
Beschreibung

If yes please complete blood sample question at this visit (if visit is performed) and perform Visit 7. Note: → All parents/guardians who signed their initial ICF of the group “All subjects” or “Carriage” and decided to be part of the Additional IR subgroup must answer “Yes” to this question. → All parents/guardians who did not perform Visit 6 must answer “NA” to this question.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
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Ähnliche Modelle

Check for continuation, elimination criteria, physical examination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
CL Item
workbook 3 (3)
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Return to visit
Item
Did the subject return for visit?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Item
No return to visit
text
C1298908 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
No return to visit, reason
Code List
No return to visit
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
If SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
If AE Number please specify
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
If solicited AE Code
text
C0683368 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Other reason for no return
Item
If other reason for no return
text
C3840932 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
Item
who made the decision
text
C0679006 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0023226 (UMLS CUI [2,3])
Decision made by Investigator, Parents/Guardians
Code List
who made the decision
CL Item
Investigator  (I)
CL Item
Parents/Guardians (P)
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
Elimination criteria become applicable
Item
Did any elimination criteria become applicable since last visit?
boolean
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Same reason and decision as previous visit.
Item
Same reason and decision as previous visit.
boolean
C0566251 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Elimination criteria: immunosuppressants/immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immune-modifying drugs.
boolean
C0680251 (UMLS CUI [1])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0005525 (UMLS CUI [3])
Elimination criteria: Major congenital defects/serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0680251 (UMLS CUI [1])
C0220810 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition.
boolean
C0680251 (UMLS CUI [1])
C0750484 (UMLS CUI [2,1])
C3829792 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C4048329 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C3829792 (UMLS CUI [4,2])
C0242114 (UMLS CUI [5,1])
C4048329 (UMLS CUI [5,2])
Elimination criteria: immunoglobulins/any blood derived products
Item
Administration of immunoglobulins and/or any blood derived products.
boolean
C0680251 (UMLS CUI [1])
C0021027 (UMLS CUI [2])
C0456388 (UMLS CUI [3])
Elimination criteria: use of investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
boolean
C0680251 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
ADDITIONAL IMMUNO ICF
C0021430 (UMLS CUI-1)
Item
Did the parents/guardians sign the additional immuno ICF?
integer
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
ICF signed for additional immuno by parents/guardians
Code List
Did the parents/guardians sign the additional immuno ICF?
CL Item
No (1)
CL Item
Yes (2)
CL Item
NA (3)
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