ID
32205
Beschrijving
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
Trefwoorden
Versies (3)
- 17-10-18 17-10-18 -
- 23-10-18 23-10-18 -
- 23-10-18 23-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 oktober 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Vaccination against pneumonia and otitis media, NCT00466947
Community-Acquired Pneumonia
- StudyEvent: ODMjoin
Beschrijving
Health care facilities
Alias
- UMLS CUI-1
- C0086388
Beschrijving
CAP suspicion in health care falicilies: Ambulatory / Outpatient
Datatype
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
Beschrijving
CAP suspicion in health care falicilies: Emergency room
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0583237
Beschrijving
CAP suspicion in health care falicilies: Hospital
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0019994
Beschrijving
pease specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0694549
- UMLS CUI [1,3]
- C0750491
- UMLS CUI [2]
- C0205394
Beschrijving
Hospital stay
Datatype
boolean
Alias
- UMLS CUI [1]
- C3489408
Beschrijving
Not necessarily consecutive days
Datatype
integer
Alias
- UMLS CUI [1]
- C3694481
Beschrijving
Stay in hospital in ICU
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3489408
- UMLS CUI [1,2]
- C0021708
Beschrijving
Not necessarily consecutive days
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3694481
- UMLS CUI [1,2]
- C0021708
Beschrijving
Chest x-ray
Alias
- UMLS CUI-1
- C0039985
Beschrijving
Reminder: Please digitalize and send X-Rays to GSK.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C1518965
Beschrijving
X-Ray department Code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017011
- UMLS CUI [1,2]
- C0805701
Beschrijving
Date of chest x-ray
Datatype
date
Alias
- UMLS CUI [1,1]
- C0039985
- UMLS CUI [1,2]
- C0011008
Beschrijving
Sequential number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1705294
Beschrijving
Laboratory tests: bacteriology normally sterile body fluid culture
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0367249
Beschrijving
NSBF culture
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
- UMLS CUI [1,4]
- C0430400
Beschrijving
NSBF
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205307
- UMLS CUI [1,2]
- C0232920
- UMLS CUI [1,3]
- C0005889
Beschrijving
Other NSBF, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C0232920
- UMLS CUI [1,4]
- C0005889
Beschrijving
Antibiotic administered
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0430400
Beschrijving
Culture result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C1274040
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C0450254
Beschrijving
Other pathogens, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0450254
- UMLS CUI [1,2]
- C0205394
Beschrijving
LABORATORY TESTS: CHEMISTRY SERUM SAMPLE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0007996
- UMLS CUI-2
- C0022885
Beschrijving
Reminder: Serum sample to be stored at -20°C and sent to the Central Lab.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0229671
- UMLS CUI [1,3]
- C0681875
Beschrijving
Date of sample collection
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample code
Datatype
text
Alias
- UMLS CUI [1]
- C0805701
Beschrijving
CRP test
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C0022885
Beschrijving
CRP local result
Datatype
float
Maateenheden
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Beschrijving
LABORATORY TESTS – HEMATOLOGY WHITE BLOOD CELL
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
- UMLS CUI-3
- C0023508
Beschrijving
Please complete table below with the results available from local lab
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0023508
- UMLS CUI [1,4]
- C1274040
Beschrijving
Date of test (WBC)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0023508
Beschrijving
Results of WBC
Datatype
integer
Maateenheden
- Cell/mL
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1274040
Beschrijving
(*) Reminder: this result should include any kind of Neutrophils PMN (i.e. bands).
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0200633
Beschrijving
Results of LYM
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0024264
Beschrijving
LABORATORY TESTS - OTHER NASOPHARYNGEAL ASPIRATE FOR CENTRAL LAB
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0205394
- UMLS CUI-3
- C0444067
Beschrijving
NPA available
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C0444067
Beschrijving
Reminder: Sample to be stored at -70°C until ship to the Cen tral Lab.
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0444067
Beschrijving
Sample code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0681875
Beschrijving
ASSESSMENT OF SEVERITY OF PNEUMONIA
Alias
- UMLS CUI-1
- C0439793
- UMLS CUI-2
- C0032285
Beschrijving
If yes, please tick all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Beschrijving
If yes, please tick all that apply.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549193
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0694549
Beschrijving
Tachypnea
Datatype
boolean
Alias
- UMLS CUI [1]
- C0231835
Beschrijving
Chest indrawing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0425469
Beschrijving
Presence of cough
Datatype
boolean
Alias
- UMLS CUI [1]
- C0010200
Beschrijving
Oxygen need / support
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030054
- UMLS CUI [1,2]
- C0815189
- UMLS CUI [2,1]
- C0030054
- UMLS CUI [2,2]
- C1521721
Beschrijving
Cyanosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0010520
Beschrijving
Grunting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0241902
Beschrijving
Abnormal auscultation findings
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004339
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
Beschrijving
If abnormal auscultation findings
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043144
Beschrijving
Hospitalization need
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0686904
Beschrijving
Inability to take food or drinks
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1299582
- UMLS CUI [1,2]
- C0013470
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0684271
Beschrijving
Lethargy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023380
Beschrijving
Irritability
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022107
Beschrijving
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Beschrijving
If yes, please complete the following table.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0694549
Beschrijving
Trade/Generic name of medication
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Reason for medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Route of medication
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Start date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
tick following box if continuing
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Medication continuing
Datatype
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])