ID

32175

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 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: 1) Blood sample. It's only for workbook 1 and 2. It has to be filled in for Visit 4, 6, 7 and 9. 2) Nasopharyngeal swabs. It's only for workbook 2 for "carriage subset". It has to be filled in for Visit 4-9.

Länk

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

Nyckelord

Versioner (5)
  1. 2018-10-22 2018-10-22 -
  2. 2018-10-22 2018-10-22 -
  3. 2018-10-23 2018-10-23 -
  4. 2018-10-23 2018-10-23 - Sarah Riepenhausen
  5. 2018-10-26 2018-10-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 oktober 2018

DOI

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Licens

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

Engelsk

Blood sample, Nasopharyngeal swabs

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit number
Beskrivning

Visit number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Beskrivning

Workbook number

Datatyp

integer

Alias
UMLS CUI [1]
C2986015
LABORATORY TESTS BLOOD SAMPLE
Beskrivning

LABORATORY TESTS BLOOD SAMPLE

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken for serology?
Beskrivning

Taking of blood sample

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1883727
If different date from visit date, blood sample
Beskrivning

Taking blood sample, different date from visit date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1883727
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0011008
NASOPHARYNGEAL SWABS
Beskrivning

NASOPHARYNGEAL SWABS

Alias
UMLS CUI-1
C0027442
UMLS CUI-2
C1261188
Has a nasopharyngeal swab been taken?
Beskrivning

Taking of nasopharyngeal swab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027442
UMLS CUI [1,2]
C1261188
UMLS CUI [1,3]
C1883727
Date of nasopharyngeal swabs taken
Beskrivning

Date of test

Datatyp

date

Alias
UMLS CUI [1,1]
C0027442
UMLS CUI [1,2]
C1261188
UMLS CUI [1,3]
C1883727
UMLS CUI [1,4]
C0011008
Bacteriological results
Beskrivning

Bacteriological results

Datatyp

integer

Alias
UMLS CUI [1]
C1254595
If positive please tick that apply
Beskrivning

It there is a positive Streptococcus pneumoniae/Haemophilus influenzae please note sample codes in following items for each. Reminder: Only in case the result is positive to Streptococcus pneumoniae/Haemophilus influenzae, the sample should be sent to Reference Lab.

Datatyp

integer

Alias
UMLS CUI [1]
C1254595
Streptococcus pneumoniae, sample code
Beskrivning

Streptococcus pneumoniae, sample code

Datatyp

text

Alias
UMLS CUI [1,1]
C0038410
UMLS CUI [1,2]
C0805701
Haemophilus influenzae, sample code
Beskrivning

Haemophilus influenzae, sample code

Datatyp

text

Alias
UMLS CUI [1,1]
C0018483
UMLS CUI [1,2]
C0805701
Other bacteriological results
Beskrivning

Please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1254595
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Similar models

Blood sample, Nasopharyngeal swabs

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 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)
Item Group
LABORATORY TESTS BLOOD SAMPLE
C0005834 (UMLS CUI-1)
Taking of blood sample
Item
Has a blood sample been taken for serology?
boolean
C0005834 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
Taking blood sample, different date from visit date
Item
If different date from visit date, blood sample
date
C0005834 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
NASOPHARYNGEAL SWABS
C0027442 (UMLS CUI-1)
C1261188 (UMLS CUI-2)
Taking of nasopharyngeal swab
Item
Has a nasopharyngeal swab been taken?
boolean
C0027442 (UMLS CUI [1,1])
C1261188 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Date of test
Item
Date of nasopharyngeal swabs taken
date
C0027442 (UMLS CUI [1,1])
C1261188 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Bacteriological results
integer
C1254595 (UMLS CUI [1])
Bacteriological results
Code List
Bacteriological results
CL Item
Negative (1)
CL Item
Positive (2)
Item
If positive please tick that apply
integer
C1254595 (UMLS CUI [1])
Bacteriological results positive
Code List
If positive please tick that apply
CL Item
Streptococcus pneumoniae (1)
CL Item
Haemophilus influenzae (2)
CL Item
Staphylococcus aureus (3)
CL Item
Streptococcus pyogenes (group A) (4)
CL Item
Moraxella Catarrhalis (5)
CL Item
Other (6)
Streptococcus pneumoniae, sample code
Item
Streptococcus pneumoniae, sample code
text
C0038410 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Haemophilus influenzae, sample code
Item
Haemophilus influenzae, sample code
text
C0018483 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Other bacteriological results
Item
Other bacteriological results
text
C0205394 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
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