ID
27340
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 GSK’s Clinical Study Register is no longer maintained for this study.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 (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”
Länk
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Nyckelord
Versioner (2)
- 2017-11-08 2017-11-08 -
- 2017-11-08 2017-11-08 -
Rättsinnehavare
Pfizer
Uppladdad den
8 november 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Visit 4 Solicited Adverse Events
- StudyEvent: ODM
Beskrivning
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beskrivning
Fever
Alias
- UMLS CUI-1
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Location of fever measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Ongoing symptom
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0015967
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0015967
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beskrivning
Medically attended visit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beskrivning
Irritability
Alias
- UMLS CUI-1
- C0022107
Beskrivning
Irritability
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beskrivning
Ongoing symptom
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0022107
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0022107
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0022107
Beskrivning
Medically attended visit Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0022107
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0022107
Beskrivning
Drowsiness
Alias
- UMLS CUI-1
- C0013144
Beskrivning
Drowsiness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013144
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Intensity of Drowsiness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beskrivning
Ongoing symptom?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0013144
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013144
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0013144
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Beskrivning
Medically attended visit Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0013144
Beskrivning
Loss of appetite
Alias
- UMLS CUI-1
- C1971624
Beskrivning
Loss of appetite
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1971624
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Loss of appetite
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beskrivning
Ongoing symptom
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C1971624
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1971624
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1971624
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Beskrivning
Medically attended visit Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C1971624
Similar models
Workbook 1 Visit 4 Solicited Adverse Events
- StudyEvent: ODM
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0015967 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,4])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0013144 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [1,4])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,4])