ID
32093
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 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 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
Stichworte
Versionen (3)
- 10/17/18 10/17/18 -
- 10/23/18 10/23/18 -
- 10/23/18 10/23/18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
October 17, 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947
Community-Acquired Pneumonia
- StudyEvent: ODMjoin
Beschreibung
Health care facilities
Alias
- UMLS CUI-1
- C0086388
Beschreibung
CAP suspicion in health care falicilies: Ambulatory / Outpatient
Datentyp
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
Beschreibung
CAP suspicion in health care falicilies: Emergency room
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0583237
Beschreibung
CAP suspicion in health care falicilies: Hospital
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0019994
Beschreibung
pease specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0205394
Beschreibung
Hospital stay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3489408
Beschreibung
Not necessarily consecutive days
Datentyp
integer
Alias
- UMLS CUI [1]
- C3694481
Beschreibung
Stay in hospital in ICU
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3489408
- UMLS CUI [1,2]
- C0021708
Beschreibung
Not necessarily consecutive days
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3694481
- UMLS CUI [1,2]
- C0021708
Beschreibung
Chest x-ray
Alias
- UMLS CUI-1
- C0039985
Beschreibung
Reminder: Please digitalize and send X-Rays to GSK.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1518965
Beschreibung
X-Ray department Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0017011
- UMLS CUI [1,2]
- C0805701
Beschreibung
Date of chest x-ray
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Beschreibung
Sequential number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1705294
Beschreibung
Laboratory tests: bacteriology normally sterile body fluid culture
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0367249
Beschreibung
NSBF culture
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
- UMLS CUI [1,4]
- C0430400
Beschreibung
NSBF
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
Beschreibung
Other NSBF, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Beschreibung
Antibiotic administered
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0430400
Beschreibung
Culture result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0450254
Beschreibung
Other pathogens, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0205394
Beschreibung
LABORATORY TESTS: CHEMISTRY SERUM SAMPLE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Beschreibung
Reminder: Serum sample to be stored at -20°C and sent to the Central Lab.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0229671
- UMLS CUI [1,3]
- C0681875
Beschreibung
Date of sample collection
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Sample code
Datentyp
text
Alias
- UMLS CUI [1]
- C0805701
Beschreibung
CRP test
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C0022885
Beschreibung
CRP local result
Datentyp
float
Maßeinheiten
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Beschreibung
LABORATORY TESTS – HEMATOLOGY WHITE BLOOD CELL
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
- UMLS CUI-3
- C0023508
Beschreibung
Please complete table below with the results available from local lab
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0023508
- UMLS CUI [1,4]
- C1274040
Beschreibung
Date of test (WBC)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0023508
Beschreibung
Results of WBC
Datentyp
integer
Maßeinheiten
- Cell/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1274040
Beschreibung
(*) Reminder: this result should include any kind of Neutrophils PMN (i.e. bands).
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0200633
Beschreibung
Results of LYM
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0024264
Beschreibung
LABORATORY TESTS - OTHER NASOPHARYNGEAL ASPIRATE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205394
- UMLS CUI-3
- C0444067
Beschreibung
NPA available
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0444067
Beschreibung
Reminder: Sample to be stored at -70°C until ship to the Cen tral Lab.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0444067
Beschreibung
Sample code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0681875
Beschreibung
ASSESSMENT OF SEVERITY OF PNEUMONIA
Alias
- UMLS CUI-1
- C0439793
- UMLS CUI-2
- C0032285
Beschreibung
If yes, please tick all that apply.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Beschreibung
If yes, please tick all that apply.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0549193
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Beschreibung
Tachypnea
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0231835
Beschreibung
Chest indrawing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0425469
Beschreibung
Presence of cough
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0010200
Beschreibung
Oxygen need / support
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030054
- UMLS CUI [1,2]
- C0815189
- UMLS CUI [2,1]
- C0030054
- UMLS CUI [2,2]
- C1521721
Beschreibung
Cyanosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0010520
Beschreibung
Grunting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0241902
Beschreibung
Abnormal auscultation findings
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004339
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
Beschreibung
If abnormal auscultation findings
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0043144
Beschreibung
Hospitalization need
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0686904
Beschreibung
Inability to take food or drinks
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0013470
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0684271
Beschreibung
Lethargy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023380
Beschreibung
Irritability
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0022107
Beschreibung
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Beschreibung
If yes, please complete the following table.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0694549
Beschreibung
Trade/Generic name of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Reason for medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Route of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Total daily dose
Datentyp
text
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Start date of medication
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
tick following box if continuing
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
Medication continuing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Ähnliche Modelle
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])