ID

27345

Beskrivning

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination 103534 (MenACWY-TT-011)

Länk

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Nyckelord

Versioner (1)
  1. 2017-11-08 2017-11-08 -
Rättsinnehavare

Pfizer

Uppladdad den

8 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976

Engelsk

Diary Card Part 1 Booster Vaccination 12-14 months of age

1 Formulär  
Administrative Documentation
Beskrivning

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Local Symptoms (at injection site)
Beskrivning

Local Symptoms (at injection site)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2700396
UMLS CUI-4
C0042196
Redness
Beskrivning

Redness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm) Day 0
Beskrivning

Size of redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 1 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 2 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 3 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 4 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 5 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 6 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Redness, size (mm) Day 7 Evening
Beskrivning

Size of Redness

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
mm
Ongoing redness after day 7?
Beskrivning

Ongoing symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
UMLS CUI [1,3]
C0332575
UMLS CUI [1,4]
C2700396
Date of last day of symptoms
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332575
UMLS CUI [1,4]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Swelling (SW)
Beskrivning

Swelling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm) Day 0
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 1 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 2 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 3 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 4 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 5 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 6 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling, size (mm) Day 7 Evening
Beskrivning

Swelling

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Ongoing swelling after day 7?
Beskrivning

Ongoing symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0038999
UMLS CUI [1,4]
C2700396
Date of last day of symptoms
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
UMLS CUI [1,4]
C0806020
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0038999
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity Day 0
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 1 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 2 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 3 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 4 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 5 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 6 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain, intensity Day 7 Evening
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Ongoing after day 7?
Beskrivning

Ongoing symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Other Local Symptoms (Day 0 to day 30)
Beskrivning

Other Local Symptoms (Day 0 to day 30)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Description - please specify side(s) and site(s)
Beskrivning

Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Intensity
Beskrivning

Intensity

Datatyp

text

Alias
UMLS CUI [1]
C0518690
Start date
Beskrivning

Start date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
End date
Beskrivning

End date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Check box if continuing
Beskrivning

Ongoing symptom

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C1457887
Tillbaka till toppen

Similar models

Diary Card Part 1 Booster Vaccination 12-14 months of age

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Local Symptoms (at injection site)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Size of redness
Item
Redness, size (mm) Day 0
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 1 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 2 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 3 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 4 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 5 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 6 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size of Redness
Item
Redness, size (mm) Day 7 Evening
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing symptom
Item
Ongoing redness after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Swelling
Item
Swelling (SW)
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm) Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 1 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 2 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 3 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 4 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 5 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 6 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling, size (mm) Day 7 Evening
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing symptom
Item
Ongoing swelling after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Code List
Pain, intensity Day 0
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 1 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 1 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 2 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 2 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 3 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 3 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 4 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 4 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 5 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 5 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 6 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 6 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Item
Pain, intensity Day 7 Evening
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity Day 7 Evening
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/protests on touch (2)
CL Item
Cries when limb is moved /spontaneously painful (3)
Ongoing symptom
Item
Ongoing after day 7?
boolean
C0521491 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item Group
Other Local Symptoms (Day 0 to day 30)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Description
Item
Description - please specify side(s) and site(s)
text
C0678257 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item
Intensity
text
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Ongoing symptom
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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