ID

32102

Beskrivning

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: 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: 1)Report of serious adverse events. It has to be filled in for workbook 1 and visit 1, 2, 3, 4, 5, 6, 7, 8 and 9. 2) Report of unsolicited adverse events. Only for workbook 2. It has to be filled in for visit 1, 2, 3, 4, 5, 6, 7, 8 and 9 3) CAP/ID/AOM case. It also has to be filled in for visit 1, 2, 3, 4, 5, 6, 7, 8 and 9. The AOM case is only for workbook 2.

Nyckelord

Versioner (3)
  1. 2018-10-17 2018-10-17 -
  2. 2018-10-23 2018-10-23 -
  3. 2018-10-26 2018-10-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 oktober 2018

DOI

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

Engelsk

Serious adverse events, unsolicited adverse events and CAP/ID/AOM case

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beskrivning

visit 4-9 not filled in for "all subjects"

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Workbook number
Beskrivning

Workbook number

Datatyp

integer

Alias
UMLS CUI [1]
C2986015
Unsolicited/serious adverse events
Beskrivning

Unsolicited/serious adverse events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C4055646
UMLS CUI-3
C1519255
Has the subject experienced any serious adverse events following vaccination at the visit
Beskrivning

For workbook 1 and 3 Please fill in the Serious Adverse Event report if SAE was detcted following vaccination.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events following vaccination at visit? If yes please fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.
Beskrivning

Only for workbook 2

Datatyp

text

Alias
UMLS CUI [1,1]
C4055646
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C4055646
UMLS CUI [2,2]
C1518404
UMLS CUI [2,3]
C0332282
UMLS CUI [2,4]
C0042196
Has the subject experienced any meningitis following vaccination at the visit
Beskrivning

Please complete an SAE report and the meningitis report if meningitis following vaccination was confirmed. Please also complete the ID section if the meningitis is caused by SP or HI.

Datatyp

text

Alias
UMLS CUI [1,1]
C0025289
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Community-Acquired Pneumonia/invasive disease/acute otitis media case
Beskrivning

Community-Acquired Pneumonia/invasive disease/acute otitis media case

Alias
UMLS CUI-1
C0694549
UMLS CUI-2
C4285937
UMLS CUI-3
C0029882
UMLS CUI-4
C0205178
Has the subject experienced any CAP following vaccination at the visit? If yes please complete the CAP section
Beskrivning

CAP following vaccination

Datatyp

text

Alias
UMLS CUI [1,1]
C0694549
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
Has the subject experienced any ID following vaccination at the visit? If yes please complete the ID section
Beskrivning

ID following vaccination

Datatyp

text

Alias
UMLS CUI [1,1]
C4285937
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
the subject experienced any AOM following vaccination at visit? If yes please complete the AOM section
Beskrivning

only for workbook 2.

Datatyp

text

Alias
UMLS CUI [1,1]
C0029882
UMLS CUI [1,2]
C0205178
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
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Similar models

Serious adverse events, unsolicited adverse events and CAP/ID/AOM case

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Gender
Code List
Visit number
CL Item
Visit 1 (1)
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)
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
Unsolicited/serious adverse events
C0877248 (UMLS CUI-1)
C4055646 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Item
Has the subject experienced any serious adverse events following vaccination at the visit
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Serious adverse events following vaccination
Code List
Has the subject experienced any serious adverse events following vaccination at the visit
CL Item
Information not available (U)
CL Item
No (N)
CL Item
Yes (Y)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events following vaccination at visit? If yes please fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.
text
C4055646 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C4055646 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
Serious or non-serious unsolicited adverse events following vaccination
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events following vaccination at visit? If yes please fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.
CL Item
Information not available (U)
CL Item
No (N)
CL Item
Yes (Y)
Item
Has the subject experienced any meningitis following vaccination at the visit
text
C0025289 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Meningitis following vaccination
Code List
Has the subject experienced any meningitis following vaccination at the visit
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Community-Acquired Pneumonia/invasive disease/acute otitis media case
C0694549 (UMLS CUI-1)
C4285937 (UMLS CUI-2)
C0029882 (UMLS CUI-3)
C0205178 (UMLS CUI-4)
Item
Has the subject experienced any CAP following vaccination at the visit? If yes please complete the CAP section
text
C0694549 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
CAP following vaccination
Code List
Has the subject experienced any CAP following vaccination at the visit? If yes please complete the CAP section
CL Item
No (N)
CL Item
Yes (Y)
Item
Has the subject experienced any ID following vaccination at the visit? If yes please complete the ID section
text
C4285937 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
ID following vaccination
Code List
Has the subject experienced any ID following vaccination at the visit? If yes please complete the ID section
CL Item
No (N)
CL Item
Yes (Y)
Item
the subject experienced any AOM following vaccination at visit? If yes please complete the AOM section
text
C0029882 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
AOM following vaccination
Code List
the subject experienced any AOM following vaccination at visit? If yes please complete the AOM section
CL Item
No (N)
CL Item
Yes (Y)
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