ID
32033
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) This document contains eligibility criteria for Workbook 1, 2 and 3. It has to be filled in before study begin. "Low Birth Weight" is an exclusion criteria for workbook 3 only.
Link
https://clinicaltrials.gov/ct2/show/NCT00466947
Keywords
Versions (2)
- 10/15/18 10/15/18 -
- 10/17/18 10/17/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 15, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947
Eligibility criteria
- StudyEvent: ODM
Description
Eligibility check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion criteria. Tick the boxes corresponding to any of the inclusion criteria the subject failed
Alias
- UMLS CUI-1
- C1512693
Description
Gender, first vaccination, age
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0042196
- UMLS CUI [3]
- C0001779
- UMLS CUI [4,1]
- C0151526
- UMLS CUI [4,2]
- C1272684
Description
living area covered by surveillance for CAP, ID, AOM
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0237096
- UMLS CUI [1,2]
- C0733511
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [2]
- C0694549
- UMLS CUI [3,1]
- C0243026
- UMLS CUI [3,2]
- C0242966
- UMLS CUI [3,3]
- C0004610
- UMLS CUI [4,1]
- C0029882
- UMLS CUI [4,2]
- C0205178
Description
Informed consent obtained from the parent or guardian of the subject.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0030551
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C1274041
Description
Health problems contraindicate the initiation of routine immunizations
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332296
- UMLS CUI [1,2]
- C1446390
- UMLS CUI [1,3]
- C1301624
- UMLS CUI [1,4]
- C0020971
Description
Protocol compliance parents/guardians
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0030551
- UMLS CUI [2,1]
- C0525058
- UMLS CUI [2,2]
- C1274041
Description
Exclusion criteria. Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Alias
- UMLS CUI-1
- C0680251
Description
Use or planned drug use of any investigational or non-registered
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [2,1]
- C0013230
- UMLS CUI [2,2]
- C1301732
Description
Use or planned use of any investigational or non-registered vaccine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C1517586
- UMLS CUI [2,1]
- C1517586
- UMLS CUI [2,2]
- C0042210
- UMLS CUI [2,3]
- C1301732
- UMLS CUI [3,1]
- C0332300
- UMLS CUI [3,2]
- C1517586
- UMLS CUI [3,3]
- C0042210
- UMLS CUI [3,4]
- C1507394
Description
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0012546
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0039614
- UMLS CUI [3,1]
- C0042196
- UMLS CUI [3,2]
- C0043167
- UMLS CUI [4,1]
- C0042196
- UMLS CUI [4,2]
- C0121772
- UMLS CUI [5,1]
- C0042196
- UMLS CUI [5,2]
- C0019159
- UMLS CUI [6,1]
- C0042196
- UMLS CUI [6,2]
- C0038410
Description
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0358314
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C1301732
- UMLS CUI [2,3]
- C0358314
- UMLS CUI [3,1]
- C0205156
- UMLS CUI [3,2]
- C0042196
- UMLS CUI [3,3]
- C0876134
- UMLS CUI [4,1]
- C0042196
- UMLS CUI [4,2]
- C1301732
- UMLS CUI [4,3]
- C0876134
Description
Allergic disease/reactions exacerbated by any component of the vaccines.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2106654
- UMLS CUI [1,2]
- C4086268
- UMLS CUI [1,3]
- C1254351
- UMLS CUI [1,4]
- C0042210
- UMLS CUI [1,5]
- C1507394
Description
History of any neurologic disorders or seizures.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0036572
Description
Acute disease (defined as the presence of a moderate or severe illness with or without fever)
Data type
boolean
Alias
- UMLS CUI [1]
- C0001314
Description
This exclusion criteria only has to be filled in for workbook 3
Data type
boolean
Alias
- UMLS CUI [1]
- C0021288
Description
Randomisation/treatment allocation
Alias
- UMLS CUI-1
- C0034656
Similar models
Eligibility criteria
- StudyEvent: ODM
C0042196 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0151526 (UMLS CUI [4,1])
C1272684 (UMLS CUI [4,2])
C0733511 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0694549 (UMLS CUI [2])
C0243026 (UMLS CUI [3,1])
C0242966 (UMLS CUI [3,2])
C0004610 (UMLS CUI [3,3])
C0029882 (UMLS CUI [4,1])
C0205178 (UMLS CUI [4,2])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C1446390 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0020971 (UMLS CUI [1,4])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0042210 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C1517586 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
C1507394 (UMLS CUI [3,4])
C0012546 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0039614 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0043167 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0121772 (UMLS CUI [4,2])
C0042196 (UMLS CUI [5,1])
C0019159 (UMLS CUI [5,2])
C0042196 (UMLS CUI [6,1])
C0038410 (UMLS CUI [6,2])
C0042196 (UMLS CUI [1,2])
C0358314 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0358314 (UMLS CUI [2,3])
C0205156 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0876134 (UMLS CUI [3,3])
C0042196 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0876134 (UMLS CUI [4,3])
C4086268 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1507394 (UMLS CUI [1,5])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])