ID
32195
Descripción
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 https://clinicalstudydatarequest.com/Posting.aspx?ID=2809 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
Palabras clave
Versiones (3)
- 17/10/18 17/10/18 -
- 23/10/18 23/10/18 -
- 23/10/18 23/10/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de octubre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947
Community-Acquired Pneumonia
- StudyEvent: ODMjoin
Descripción
Health care facilities
Alias
- UMLS CUI-1
- C0086388
Descripción
CAP suspicion in health care falicilies: Ambulatory / Outpatient
Tipo de datos
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
Descripción
CAP suspicion in health care falicilies: Emergency room
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0583237
Descripción
CAP suspicion in health care falicilies: Hospital
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0019994
Descripción
pease specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0205394
Descripción
Hospital stay
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3489408
Descripción
Not necessarily consecutive days
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3694481
Descripción
Stay in hospital in ICU
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3489408
- UMLS CUI [1,2]
- C0021708
Descripción
Not necessarily consecutive days
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3694481
- UMLS CUI [1,2]
- C0021708
Descripción
Chest x-ray
Alias
- UMLS CUI-1
- C0039985
Descripción
Reminder: Please digitalize and send X-Rays to GSK.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1518965
Descripción
X-Ray department Code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0017011
- UMLS CUI [1,2]
- C0805701
Descripción
Date of chest x-ray
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Descripción
Sequential number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1705294
Descripción
Laboratory tests: bacteriology normally sterile body fluid culture
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0367249
Descripción
NSBF culture
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
- UMLS CUI [1,4]
- C0430400
Descripción
NSBF
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
Descripción
Other NSBF, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Descripción
Antibiotic administered
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0430400
Descripción
Culture result
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0450254
Descripción
Other pathogens, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0205394
Descripción
LABORATORY TESTS: CHEMISTRY SERUM SAMPLE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Descripción
Reminder: Serum sample to be stored at -20°C and sent to the Central Lab.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0229671
- UMLS CUI [1,3]
- C0681875
Descripción
Date of sample collection
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
Sample code
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0805701
Descripción
CRP test
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C0022885
Descripción
CRP local result
Tipo de datos
float
Unidades de medida
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Descripción
LABORATORY TESTS – HEMATOLOGY WHITE BLOOD CELL
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
- UMLS CUI-3
- C0023508
Descripción
Please complete table below with the results available from local lab
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0023508
- UMLS CUI [1,4]
- C1274040
Descripción
Date of test (WBC)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0023508
Descripción
Results of WBC
Tipo de datos
integer
Unidades de medida
- Cell/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1274040
Descripción
(*) Reminder: this result should include any kind of Neutrophils PMN (i.e. bands).
Tipo de datos
float
Unidades de medida
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0200633
Descripción
Results of LYM
Tipo de datos
float
Unidades de medida
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0024264
Descripción
LABORATORY TESTS - OTHER NASOPHARYNGEAL ASPIRATE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205394
- UMLS CUI-3
- C0444067
Descripción
NPA available
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0444067
Descripción
Reminder: Sample to be stored at -70°C until ship to the Cen tral Lab.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0444067
Descripción
Sample code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0681875
Descripción
ASSESSMENT OF SEVERITY OF PNEUMONIA
Alias
- UMLS CUI-1
- C0439793
- UMLS CUI-2
- C0032285
Descripción
If yes, please tick all that apply.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Descripción
If yes, please tick all that apply.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0549193
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Descripción
Tachypnea
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0231835
Descripción
Chest indrawing
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0425469
Descripción
Presence of cough
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0010200
Descripción
Oxygen need / support
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0030054
- UMLS CUI [1,2]
- C0815189
- UMLS CUI [2,1]
- C0030054
- UMLS CUI [2,2]
- C1521721
Descripción
Cyanosis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0010520
Descripción
Grunting
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0241902
Descripción
Abnormal auscultation findings
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004339
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
Descripción
If abnormal auscultation findings
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0043144
Descripción
Hospitalization need
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0686904
Descripción
Inability to take food or drinks
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0013470
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0684271
Descripción
Lethargy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0023380
Descripción
Irritability
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0022107
Descripción
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Descripción
If yes, please complete the following table.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0694549
Descripción
Trade/Generic name of medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Reason for medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Descripción
Route of medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Total daily dose
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348070
Descripción
Start date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
tick following box if continuing
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
Medication continuing
Tipo de datos
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])