ID

32192

Description

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

Keywords

Versions (3)
  1. 22/10/18 22/10/18 -
  2. 23/10/18 23/10/18 -
  3. 26/10/18 26/10/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

23 de octubre de 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Vaccination against pneumonia and otitis media 109563, NCT00466947

English

Check for continuation, elimination criteria, physical examination

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

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

CHECK FOR STUDY CONTINUATION

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

If subject return to visit please complete the next pages

Data type

boolean

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

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.

Data type

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
Description

Please complete and submit SAE report

Data type

integer

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

Please complete Non-serious Adverse Event section

Data type

integer

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

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

Data type

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
Description

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

Data type

text

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

Decision made by Investigator, Parents/Guardians

Data type

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
Description

ELIMINATION CRITERIA

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

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

Data type

boolean

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

For Visit 3-9

Data type

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.
Description

Chronic administration is defined as more than 14 days

Data type

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.
Description

Elimination criteria: Major congenital defects/serious chronic illness.

Data type

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.
Description

Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.

Data type

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.
Description

Elimination criteria: immunoglobulins/any blood derived products

Data type

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).
Description

Elimination criteria: use of investigational or non-registered product

Data type

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
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ADDITIONAL IMMUNO ICF
Description

ADDITIONAL IMMUNO ICF

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

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.

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Back to the top of the page

Similar models

Check for continuation, elimination criteria, physical examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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