ID

32077

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) 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 general medical history, physical examination, risk factors and vaccination history. It has to be filled in for Visit 1 for all workbooks.

Link

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

Keywords

Versions (2)
  1. 10/15/18 10/15/18 -
  2. 10/17/18 10/17/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

DOI

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License

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

English

Medical history, Physical Examination, Risk factors, Vaccination history

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
general medical history/ physical examination, MedDRA System Organ Class
Description

general medical history/ physical examination, MedDRA System Organ Class

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
UMLS CUI-3
C2347091
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study? If yes please give diagnosis and tick appropriate Past/Current box(es).
Description

Pre-existing conditions, signs or symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C2347662
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
pre-existing conditions, signs or symptoms in past
Description

Disease in past

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444637
Current pre-existing conditions, signs or symptoms
Description

Current disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0012634
Risk factors for participation in study
Description

Risk factors for participation in study

Alias
UMLS CUI-1
C0035648
Are there any risk factor(s) for Pneumococcal and/or H.influenzae infections?
Description

Risk factor(s) for Pneumococcal and/or H.influenzae infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0032269
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0018483
UMLS CUI [2,3]
C0009450
Risk factor: Agammaglobulinemia
Description

Risk factor: Agammaglobulinemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0001768
Risk factor: HIV infection
Description

Risk factor: HIV infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0019693
Risk factor: Sickle cell disease
Description

Risk factor: Sickle cell disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0002895
Risk factor: Surgical asplenia
Description

Risk factor: splenectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0037995
Risk factor: Nephrotic syndrome
Description

Risk factor: Nephrotic syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0027726
Risk factor: Chronic renal failure
Description

Risk factor: Chronic renal failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0035078
UMLS CUI [1,3]
C0205191
Risk factor: Organ transplantation
Description

Risk factor: Organ transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0029216
Risk factor: Diabetes mellitus
Description

Risk factor: Diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0011849
Risk factor: Congestive heart failure
Description

Risk factor: Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0018802
Risk factor: CSF leaks
Description

Risk factor: CSF leaks

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C0919691
Other risk factors
Description

Other risk factors

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0205394
Sepcify the other risk factor
Description

Sepcify other risk factor

Data type

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0205394
Does the child receive breast-feeding?
Description

Breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
Household number of less than 5 years old siblings?
Description

Household number of less than 5 years old siblings

Data type

integer

Alias
UMLS CUI [1,1]
C0020052
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0037047
UMLS CUI [1,4]
C0001779
Vaccination history
Description

Vaccination history

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0019664
Has the subject received any vaccination since birth? if yes please complete the following table
Description

Any vaccination since birth

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0005615
Trade / Generic Name of vaccines
Description

Trade / Generic Name

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route of vaccines
Description

Route of vaccines

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Dose Number of vaccine
Description

Dose Number of vaccine

Data type

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Estimated date of vaccine.
Description

Enter approximate date in case the exact date is unknown. Reminder: Any vaccine should be administered at least 30 days before the date of study vaccine administration

Data type

partialDate

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
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Similar models

Medical history, Physical Examination, Risk factors, Vaccination history

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
general medical history/ physical examination, MedDRA System Organ Class
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C2347091 (UMLS CUI-3)
Pre-existing conditions, signs or symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study? If yes please give diagnosis and tick appropriate Past/Current box(es).
boolean
C0521987 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac  (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations  (16)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (19)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Disease in past
Item
pre-existing conditions, signs or symptoms in past
boolean
C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Current disease
Item
Current pre-existing conditions, signs or symptoms
boolean
C0521116 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Risk factors for participation in study
C0035648 (UMLS CUI-1)
Risk factor(s) for Pneumococcal and/or H.influenzae infections
Item
Are there any risk factor(s) for Pneumococcal and/or H.influenzae infections?
boolean
C0035648 (UMLS CUI [1,1])
C0032269 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0018483 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
Risk factor: Agammaglobulinemia
Item
Risk factor: Agammaglobulinemia
boolean
C0035648 (UMLS CUI [1,1])
C0001768 (UMLS CUI [1,2])
Risk factor: HIV infection
Item
Risk factor: HIV infection
boolean
C0035648 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
Risk factor: Sickle cell disease
Item
Risk factor: Sickle cell disease
boolean
C0035648 (UMLS CUI [1,1])
C0002895 (UMLS CUI [1,2])
Risk factor: splenectomy
Item
Risk factor: Surgical asplenia
boolean
C0035648 (UMLS CUI [1,1])
C0037995 (UMLS CUI [1,2])
Risk factor: Nephrotic syndrome
Item
Risk factor: Nephrotic syndrome
boolean
C0035648 (UMLS CUI [1,1])
C0027726 (UMLS CUI [1,2])
Risk factor: Chronic renal failure
Item
Risk factor: Chronic renal failure
boolean
C0035648 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Risk factor: Organ transplantation
Item
Risk factor: Organ transplantation
boolean
C0035648 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
Risk factor: Diabetes mellitus
Item
Risk factor: Diabetes mellitus
boolean
C0035648 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Risk factor: Congestive heart failure
Item
Risk factor: Congestive heart failure
boolean
C0035648 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
Risk factor: CSF leaks
Item
Risk factor: CSF leaks
boolean
C0035648 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C0919691 (UMLS CUI [1,3])
Other risk factors
Item
Other risk factors
boolean
C0035648 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Sepcify other risk factor
Item
Sepcify the other risk factor
text
C0035648 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Breast-feeding
Item
Does the child receive breast-feeding?
boolean
C0006147 (UMLS CUI [1])
Household number of less than 5 years old siblings
Item
Household number of less than 5 years old siblings?
integer
C0020052 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0037047 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
Item Group
Vaccination history
C0042196 (UMLS CUI-1)
C0019664 (UMLS CUI-2)
Item
Has the subject received any vaccination since birth? if yes please complete the following table
integer
C0042196 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
Any vaccination since birth
Code List
Has the subject received any vaccination since birth? if yes please complete the following table
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Trade / Generic Name
Item
Trade / Generic Name of vaccines
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route of vaccines
Item
Route of vaccines
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Dose Number of vaccine
Item
Dose Number of vaccine
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Estimated date of vaccine
Item
Estimated date of vaccine.
partialDate
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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