ID
27324
Beskrivning
Study ID: 103533 Clinical Study ID: 103533 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 GSK’s Clinical Study Register is no longer maintained for this study.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
Länk
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Nyckelord
Versioner (1)
- 08-11-17 08-11-17 -
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
Diary Card Part 2 Vaccination 1 3-5 years of age
- 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
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever
Datatyp
float
Måttenheter
- °C
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
Medically attended visit
Datatyp
boolean
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
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
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0013144
Beskrivning
Contact information
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1880174
- UMLS CUI [1,2]
- C0019993
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
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1971624
Beskrivning
Other General Symptoms (Day 0 to day 30)
Alias
- UMLS CUI-1
- C0029625
Beskrivning
Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0029625
Beskrivning
Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710066
- UMLS CUI [1,2]
- C0159028
Beskrivning
Start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0159028
Beskrivning
End date
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0159028
Beskrivning
Ongoing Symptom
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C3174772
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0159028
Beskrivning
Medication - Please fill in below if any medication has been taken since the vaccination
Alias
- UMLS CUI-1
- C0013227
Beskrivning
Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Beskrivning
Reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Total Daily Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beskrivning
Start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
End date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
Ongoing medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Similar models
Diary Card Part 2 Vaccination 1 3-5 years of age
- StudyEvent: ODM
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
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])
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])
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])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C0019993 (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])
C0522510 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C0029625 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
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