ID
32205
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 ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00466947: 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 Community-Acquired Pneumonia (CAP) form. It has to be filled in if a CAP case occurs during study. It is for all workbooks.
Link
https://clinicaltrials.gov/ct2/show/NCT00466947
Keywords
Versions (3)
- 10/17/18 10/17/18 -
- 10/23/18 10/23/18 -
- 10/23/18 10/23/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 23, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947
Community-Acquired Pneumonia
- StudyEvent: ODMjoin
Description
Health care facilities
Alias
- UMLS CUI-1
- C0086388
Description
CAP suspicion in health care falicilies: Ambulatory / Outpatient
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2,1]
- C0439841
- UMLS CUI [2,2]
- C0029921
Description
CAP suspicion in health care falicilies: Emergency room
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0583237
Description
CAP suspicion in health care falicilies: Hospital
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0019994
Description
pease specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0205394
Description
Hospital stay
Data type
boolean
Alias
- UMLS CUI [1]
- C3489408
Description
Not necessarily consecutive days
Data type
integer
Alias
- UMLS CUI [1]
- C3694481
Description
Stay in hospital in ICU
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3489408
- UMLS CUI [1,2]
- C0021708
Description
Not necessarily consecutive days
Data type
integer
Alias
- UMLS CUI [1,1]
- C3694481
- UMLS CUI [1,2]
- C0021708
Description
Chest x-ray
Alias
- UMLS CUI-1
- C0039985
Description
Reminder: Please digitalize and send X-Rays to GSK.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1518965
Description
X-Ray department Code
Data type
text
Alias
- UMLS CUI [1,1]
- C0017011
- UMLS CUI [1,2]
- C0805701
Description
Date of chest x-ray
Data type
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Description
Sequential number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1705294
Description
Laboratory tests: bacteriology normally sterile body fluid culture
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0367249
Description
NSBF culture
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
- UMLS CUI [1,4]
- C0430400
Description
NSBF
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
Description
Other NSBF, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Description
Antibiotic administered
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0430400
Description
Culture result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Description
List of pathogens that can be isolated from blood in the context of a CAP case with bacteremia. Reminder: In case positive to Haemophilus influenzae or Streptococcus pneumoniae, please complete the ID section and send a sample to Reference Lab for confirmation.
Data type
text
Alias
- UMLS CUI [1]
- C0450254
Description
Other pathogens, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0205394
Description
LABORATORY TESTS: CHEMISTRY SERUM SAMPLE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Description
Reminder: Serum sample to be stored at -20°C and sent to the Central Lab.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0229671
- UMLS CUI [1,3]
- C0681875
Description
Date of sample collection
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample code
Data type
text
Alias
- UMLS CUI [1]
- C0805701
Description
CRP test
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C0022885
Description
CRP local result
Data type
float
Measurement units
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Description
LABORATORY TESTS – HEMATOLOGY WHITE BLOOD CELL
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
- UMLS CUI-3
- C0023508
Description
Please complete table below with the results available from local lab
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0023508
- UMLS CUI [1,4]
- C1274040
Description
Date of test (WBC)
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0023508
Description
Results of WBC
Data type
integer
Measurement units
- Cell/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1274040
Description
(*) Reminder: this result should include any kind of Neutrophils PMN (i.e. bands).
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0200633
Description
Results of LYM
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0024264
Description
LABORATORY TESTS - OTHER NASOPHARYNGEAL ASPIRATE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205394
- UMLS CUI-3
- C0444067
Description
NPA available
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0444067
Description
Reminder: Sample to be stored at -70°C until ship to the Cen tral Lab.
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0444067
Description
Sample code
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0681875
Description
ASSESSMENT OF SEVERITY OF PNEUMONIA
Alias
- UMLS CUI-1
- C0439793
- UMLS CUI-2
- C0032285
Description
If yes, please tick all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Description
If yes, please tick all that apply.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0549193
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Description
Tachypnea
Data type
boolean
Alias
- UMLS CUI [1]
- C0231835
Description
Chest indrawing
Data type
boolean
Alias
- UMLS CUI [1]
- C0425469
Description
Presence of cough
Data type
boolean
Alias
- UMLS CUI [1]
- C0010200
Description
Oxygen need / support
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030054
- UMLS CUI [1,2]
- C0815189
- UMLS CUI [2,1]
- C0030054
- UMLS CUI [2,2]
- C1521721
Description
Cyanosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0010520
Description
Grunting
Data type
boolean
Alias
- UMLS CUI [1]
- C0241902
Description
Abnormal auscultation findings
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004339
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
Description
If abnormal auscultation findings
Data type
boolean
Alias
- UMLS CUI [1]
- C0043144
Description
Hospitalization need
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0686904
Description
Inability to take food or drinks
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0013470
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0684271
Description
Lethargy
Data type
boolean
Alias
- UMLS CUI [1]
- C0023380
Description
Irritability
Data type
boolean
Alias
- UMLS CUI [1]
- C0022107
Description
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Description
If yes, please complete the following table.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0694549
Description
Trade/Generic name of medication
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Reason for medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Route of medication
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Total daily dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Start date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
tick following box if continuing
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
Community-Acquired Pneumonia
- StudyEvent: ODMjoin
C0694549 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0694549 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0439841 (UMLS CUI [2,1])
C0029921 (UMLS CUI [2,2])
C0694549 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
C0694549 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0019994 (UMLS CUI [2])
C0694549 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C0021708 (UMLS CUI [1,2])
C0021708 (UMLS CUI [1,2])
C1518965 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1705294 (UMLS CUI [1,2])
C0367249 (UMLS CUI-2)
C0232920 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0430400 (UMLS CUI [1,4])
C0232920 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,2])
C0232920 (UMLS CUI [1,3])
C0005889 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,2])
C0232920 (UMLS CUI [1,3])
C0005889 (UMLS CUI [1,4])
C0332152 (UMLS CUI [1,2])
C0430400 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0229671 (UMLS CUI [1,2])
C0681875 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0023508 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0023508 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0200633 (UMLS CUI [1,2])
C0024264 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0444067 (UMLS CUI-3)
C0444067 (UMLS CUI [1,2])
C0444067 (UMLS CUI [1,2])
C0681875 (UMLS CUI [1,2])
C0032285 (UMLS CUI-2)
C0347984 (UMLS CUI [1,2])
C0694549 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0694549 (UMLS CUI [1,3])
C0815189 (UMLS CUI [1,2])
C0030054 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0686904 (UMLS CUI [1,2])
C0013470 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0684271 (UMLS CUI [2,2])
C0694549 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])