ID
27339
Beschrijving
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 GSK’s Clinical Study Register is no longer maintained for this study.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 (Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 12 – 14 months of age”
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Trefwoorden
Versies (2)
- 08-11-17 08-11-17 -
- 08-11-17 08-11-17 -
Houder van rechten
Pfizer
Geüploaded op
8 november 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Visit 4 Vaccination
- StudyEvent: ODM
Beschrijving
VACCINE ADMINISTRATION
Alias
- UMLS CUI-1
- C2368628
Beschrijving
Date of vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Beschrijving
temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0332152
Beschrijving
Route of Measurement
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0449687
Beschrijving
Vaccine Administration
Datatype
text
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Reason Vaccine not administered
Datatype
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Beschrijving
Decision
Datatype
text
Alias
- UMLS CUI [1]
- C0679006
Beschrijving
undefined item
Datatype
text
Beschrijving
Vaccine administration
Datatype
boolean
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccine administration Side
Datatype
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschrijving
Vaccine administration site
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschrijving
Vaccine administration route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
Post vaccination observation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1443955
- UMLS CUI [1,2]
- C0700325
Beschrijving
Unsolicited adverse events
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Beschrijving
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
- UMLS CUI-4
- C0877248
Beschrijving
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
- UMLS CUI-4
- C0877248
Beschrijving
Redness
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beschrijving
Size of redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size of Redness
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0332575
- UMLS CUI [1,4]
- C2700396
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0332575
- UMLS CUI [1,4]
- C2700396
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschrijving
Medically attended visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschrijving
Swelling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Swelling
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0038999
- UMLS CUI [1,4]
- C2700396
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
- UMLS CUI [1,4]
- C0806020
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0038999
Beschrijving
Medically attended visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0038999
Beschrijving
undefined item
Datatype
text
Beschrijving
Pain
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Beschrijving
Medically attended visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
Similar models
Workbook 1 Visit 4 Vaccination
- StudyEvent: ODM
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0700325 (UMLS CUI [1,2])
C0042196 (UMLS CUI-2)
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C2700396 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])