ID

32338

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 ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/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 study conclusion form. It's for all workbooks.

Link

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

Stichworte

Versionen (2)
  1. 26.10.18 26.10.18 -
  2. 27.10.18 27.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. Oktober 2018

DOI

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

Englisch

Study conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study conclusion
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Date of study conclusion
Beschreibung

Date of study conclusion

Datentyp

date

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0011008
STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT
Beschreibung

STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
UMLS CUI-3
C1519255
Did the subject experience any Serious Adverse Event during the study?
Beschreibung

Serious Adverse Event during study

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
If Serious Adverse Event during the study occured, please specify total number of SAE's
Beschreibung

Total number of SAE's

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
STATUS OF TREATMENT BLIND
Beschreibung

STATUS OF TREATMENT BLIND

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the subject unblinding event record during the study?
Beschreibung

Complete Serious Adverse Event report as appropriate. For workbook 2 you can also complete Non-Serious Adverse Event section as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
If subject unblinding event record, complete the date
Beschreibung

Subject unblinding event record, date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3897431
UMLS CUI [1,3]
C2347038
Subject unblinding event record, reason
Beschreibung

Subject unblinding event record, reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0566251
If other reason for subject unblinding event record, please specify
Beschreibung

Other reason for subject unblinding event record

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347038
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0566251
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.

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
Chronic administration of immunosuppressants or other immune-modifying drugs.
Beschreibung

Chronic administration is defined as more than 14 days

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
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]
C0042210
UMLS CUI [2,3]
C1444655
UMLS CUI [2,4]
C2348563
Withdrawing from study
Beschreibung

Withdrawing from study

Alias
UMLS CUI-1
C0422727
Was the subject withdrawn from the study?
Beschreibung

If yes, note major reason. Therefore tick one of the following items

Datentyp

text

Alias
UMLS CUI [1]
C0422727
Reason for withdrawal
Beschreibung

If you tick SAE, please complete and submit SAE report. If you tick AEX, please complete Non-serious Adverse Event section.

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
If SAE, please specify SAE Number
Beschreibung

Please complete and submit SAE report

Datentyp

integer

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

Please complete Non-serious Adverse Event section

Datentyp

integer

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

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C0683368
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C1518404
UMLS CUI [1,4]
C0805701
If protocol violation, please specify
Beschreibung

Protocol violation

Datentyp

text

Alias
UMLS CUI [1]
C1709750
If other reason for withdrawal, please specify
Beschreibung

Withdrawal, other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C3840932
Who made the decision
Beschreibung

Dicision made by

Datentyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0682237
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact
Beschreibung

If you tick No, please give details in Adverse Events section.

Datentyp

text

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C1142435
INVESTIGATOR'S SIGNATURE
Beschreibung

INVESTIGATOR'S SIGNATURE

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Study conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study conclusion
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
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)
Date of study conclusion
Item
Date of study conclusion
date
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Item
Did the subject experience any Serious Adverse Event during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Serious Adverse Event during study
Code List
Did the subject experience any Serious Adverse Event during the study?
CL Item
No (N)
CL Item
Yes (Y)
Total number of SAE's
Item
If Serious Adverse Event during the study occured, please specify total number of SAE's
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
STATUS OF TREATMENT BLIND
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the subject unblinding event record during the study?
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Treatment blind broken
Code List
Was the subject unblinding event record during the study?
CL Item
No  (N)
CL Item
Yes (Y)
Subject unblinding event record, date
Item
If subject unblinding event record, complete the date
date
C0011008 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,3])
Item
Subject unblinding event record, reason
integer
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Treatment blind broken, reason
Code List
Subject unblinding event record, reason
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (9)
Other reason for subject unblinding event record
Item
If other reason for subject unblinding event record, please specify
text
C3897431 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
Item
Did any elimination criteria become applicable since last visit?
text
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Elimination criteria become applicable
Code List
Did any elimination criteria become applicable since last visit?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria: immunosuppressants/immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immune-modifying drugs.
boolean
C0680251 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [1,4])
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])
C0042210 (UMLS CUI [2,2])
C1444655 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Item Group
Withdrawing from study
C0422727 (UMLS CUI-1)
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Withdrawal from study
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for withdrawal
Code List
Reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
SAE Number
Item
If SAE, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
If AEX, please specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
If AEX, please specify solicited AE Code
integer
C0683368 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Protocol violation
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Withdrawal, other reason
Item
If other reason for withdrawal, please specify
text
C2349954 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Item
Who made the decision
text
C0679006 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0682237 (UMLS CUI [1,3])
Dicision made by
Code List
Who made the decision
CL Item
Investigator  (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
Condition at date of last contact
Code List
Was the subject in good condition at date of last contact
CL Item
No (N)
CL Item
Yes (Y)
Item Group
INVESTIGATOR'S SIGNATURE
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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