ID
27340
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 GSK’s Clinical Study Register is no longer maintained for this study.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 Solicited Adverse Events
- StudyEvent: ODM
Beschrijving
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beschrijving
Fever
Alias
- UMLS CUI-1
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Location of fever measurement
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0015967
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0015967
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beschrijving
Medically attended visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Beschrijving
Irritability
Alias
- UMLS CUI-1
- C0022107
Beschrijving
Irritability
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0022107
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0022107
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0022107
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0022107
Beschrijving
Medically attended visit Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0022107
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0022107
Beschrijving
Drowsiness
Alias
- UMLS CUI-1
- C0013144
Beschrijving
Drowsiness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013144
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Intensity of Drowsiness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0522510
Beschrijving
Ongoing symptom?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C0013144
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013144
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0013144
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Beschrijving
Medically attended visit Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C0013144
Beschrijving
Loss of appetite
Alias
- UMLS CUI-1
- C1971624
Beschrijving
Loss of appetite
Datatype
boolean
Alias
- UMLS CUI [1]
- C1971624
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Loss of appetite
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0522510
Beschrijving
Ongoing symptom
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
- UMLS CUI [1,3]
- C1971624
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1971624
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C1971624
Beschrijving
Medically attended visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Beschrijving
Medically attended visit Type
Datatype
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])