ID

32078

Beskrivning

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.

Länk

https://clinicaltrials.gov/ct2/show/NCT00466947

Nyckelord

Versioner (2)
  1. 2018-10-15 2018-10-15 -
  2. 2018-10-17 2018-10-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media, NCT00466947

Engelsk

Eligibility criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Beskrivning

Workbook number

Datatyp

integer

Alias
UMLS CUI [1]
C2986015
Eligibility check
Beskrivning

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beskrivning

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datatyp

boolean

Alias
UMLS CUI [1]
C1512693
Inclusion criteria. Tick the boxes corresponding to any of the inclusion criteria the subject failed
Beskrivning

Inclusion criteria. Tick the boxes corresponding to any of the inclusion criteria the subject failed

Alias
UMLS CUI-1
C1512693
male or female between, and including, 6 and 16 weeks of age (between 42 and 118 days) at the time of the first vaccination. Pre-term born infants (born after a gestation period of less than 37 weeks) can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age (between 56 and 118 days).
Beskrivning

Gender, first vaccination, age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0042196
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0151526
UMLS CUI [4,2]
C1272684
In each site, subjects should be living in the area covered by the surveillance system for CAP, ID and AOM (see country specific LPPs).
Beskrivning

living area covered by surveillance for CAP, ID, AOM

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0733511
UMLS CUI [2,1]
C0733511
UMLS CUI [2,2]
C0694549
UMLS CUI [3,1]
C0733511
UMLS CUI [3,2]
C4285937
UMLS CUI [4,1]
C0733511
UMLS CUI [4,2]
C0029882
UMLS CUI [4,3]
C0205178
Written informed consent obtained from the parent or guardian of the subject.
Beskrivning

Informed consent obtained from the parent or guardian of the subject.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
Beskrivning

Health problems contraindicate the initiation of routine immunizations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C1446390
UMLS CUI [1,3]
C1301624
UMLS CUI [1,4]
C0020971
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
Beskrivning

Protocol compliance parents/guardians

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
Exclusion criteria. Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Beskrivning

Exclusion criteria. Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or planned use during the study period.
Beskrivning

Use or planned drug use of any investigational or non-registered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1301732
Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
Beskrivning

Use or planned use of any investigational or non-registered vaccine

Datatyp

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
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
Beskrivning

Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.

Datatyp

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
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
Beskrivning

Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.

Datatyp

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
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Beskrivning

Allergic disease/reactions exacerbated by any component of the vaccines.

Datatyp

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
History of any neurologic disorders or seizures.
Beskrivning

History of any neurologic disorders or seizures.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0036572
Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
Beskrivning

Acute disease (defined as the presence of a moderate or severe illness with or without fever)

Datatyp

boolean

Alias
UMLS CUI [1]
C0001314
Infants with low birth weight (<2.500g) (Amended 25 November 2008).
Beskrivning

This exclusion criteria only has to be filled in for workbook 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0021288
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Similar models

Eligibility criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
CL Item
workbook 3 (3)
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
Inclusion criteria
Item
Did the subject meet all the entry criteria?
boolean
C1512693 (UMLS CUI [1])
Item Group
Inclusion criteria. Tick the boxes corresponding to any of the inclusion criteria the subject failed
C1512693 (UMLS CUI-1)
Gender, first vaccination, age
Item
male or female between, and including, 6 and 16 weeks of age (between 42 and 118 days) at the time of the first vaccination. Pre-term born infants (born after a gestation period of less than 37 weeks) can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age (between 56 and 118 days).
boolean
C0079399 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0151526 (UMLS CUI [4,1])
C1272684 (UMLS CUI [4,2])
living area covered by surveillance for CAP, ID, AOM
Item
In each site, subjects should be living in the area covered by the surveillance system for CAP, ID and AOM (see country specific LPPs).
boolean
C0237096 (UMLS CUI [1,1])
C0733511 (UMLS CUI [1,2])
C0733511 (UMLS CUI [2,1])
C0694549 (UMLS CUI [2,2])
C0733511 (UMLS CUI [3,1])
C4285937 (UMLS CUI [3,2])
C0733511 (UMLS CUI [4,1])
C0029882 (UMLS CUI [4,2])
C0205178 (UMLS CUI [4,3])
Informed consent obtained from the parent or guardian of the subject.
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Health problems contraindicate the initiation of routine immunizations
Item
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
boolean
C0332296 (UMLS CUI [1,1])
C1446390 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0020971 (UMLS CUI [1,4])
Protocol compliance parents/guardians
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
Exclusion criteria. Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
C0680251 (UMLS CUI-1)
Use or planned drug use of any investigational or non-registered
Item
Use of any investigational or non-registered drug or planned use during the study period.
boolean
C0521116 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Use or planned use of any investigational or non-registered vaccine
Item
Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
boolean
C0521116 (UMLS CUI [1,1])
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])
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
Item
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
boolean
C0042196 (UMLS CUI [1,1])
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])
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
Item
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
boolean
C0205156 (UMLS CUI [1,1])
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])
Allergic disease/reactions exacerbated by any component of the vaccines.
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C2106654 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1507394 (UMLS CUI [1,5])
History of any neurologic disorders or seizures.
Item
History of any neurologic disorders or seizures.
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
Acute disease (defined as the presence of a moderate or severe illness with or without fever)
Item
Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
boolean
C0001314 (UMLS CUI [1])
Low birth weight
Item
Infants with low birth weight (<2.500g) (Amended 25 November 2008).
boolean
C0021288 (UMLS CUI [1])
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