ID

32194

Beschreibung

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 information about demography, administrative data and origin. It has to be filled out in all workbooks for vist 1.

Link

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

Stichworte

Versionen (4)
  1. 15/10/2018 15/10/2018 -
  2. 17/10/2018 17/10/2018 -
  3. 23/10/2018 23/10/2018 -
  4. 23/10/2018 23/10/2018 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23 octobre 2018

DOI

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Lizenz

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

Englisch

Demographics, administrative data, race

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure. (Date of informed consent)
Beschreibung

Date of informed consent

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
RANDOMISATION / TREATMENT ALLOCATION
Beschreibung

RANDOMISATION / TREATMENT ALLOCATION

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschreibung

Record treatment number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Demographics data
Beschreibung

Demographics data

Alias
UMLS CUI-1
C0011298
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
American Hispanic or Latino
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Specify
Beschreibung

Other race

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Gestational age
Beschreibung

Gestational age

Datentyp

integer

Maßeinheiten
  • weeks
Alias
UMLS CUI [1]
C0017504
weeks
Origine
Beschreibung

Origine

Alias
UMLS CUI-1
C2348568
Has the subject been enrolled after the Amendment 1 approval?
Beschreibung

Date of approval of the protocol amendment 1: For workbook 1: 6 of May 2008 For workbook 2: 27 of May 2008

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205345
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Demographics, administrative data, race

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
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
Informed Consent
C0021430 (UMLS CUI-1)
Date of informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure. (Date of informed consent)
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
RANDOMISATION / TREATMENT ALLOCATION
C0034656 (UMLS CUI-1)
Record treatment number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Demographics data
C0011298 (UMLS CUI-1)
Center number
Item
Center number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
American Hispanic or Latino
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
American Hispanic or Latino
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (10)
Other race
Item
Specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male,F=female (M)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Gestational age
Item
Gestational age
integer
C0017504 (UMLS CUI [1])
Item Group
Origine
C2348568 (UMLS CUI-1)
Relative Enrollment Date
Item
Has the subject been enrolled after the Amendment 1 approval?
boolean
C0205345 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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