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ID
27324
Beschreibung
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Stichworte
Versionen (1)
- 08.11.17 08.11.17 -
Rechteinhaber
Pfizer
Hochgeladen am
8. November 2017
DOI
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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
Ähnliche Modelle
Diary Card Part 2 Vaccination 1 3-5 years of age
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date Diary Card return
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
Item Group
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If yes is ticked, please complete all items. (Y)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Location of fever measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
CL Item
Axillary (A)
CL Item
rectal (R)
Fever
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 1 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 2 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 3 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 4 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 5 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 6 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 7 Evening
float
C0015967 (UMLS CUI [1])
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Irritability
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of Irritability/fussiness Day 1 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of Irritability/fussiness Day 2 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness day 3 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness day 4 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 5 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 6 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 7 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
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])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness Intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 1 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of drowsiness Day 2 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 3 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 4 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 5 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 6 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 7 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Ongoing symptom?
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Contact information
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text
C1880174 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite, Intensity Day 0
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 1 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity day 2 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 3 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 4 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 5 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 6 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 7 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Description
Item
Description - please give details below
text
C0678257 (UMLS CUI [1,1])
C0029625 (UMLS CUI [1,2])
C0029625 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
End date
Item
End date
text
C0806020 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Ongoing Symptom
Item
Check box if continuing
boolean
C0159028 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Item Group
Medication - Please fill in below if any medication has been taken since the vaccination
C0013227 (UMLS CUI-1)
Medication
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Ongoing medication
Item
Check box if continuing
boolean
C2826666 (UMLS CUI [1])
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