Informations:
Erreur:
ID
27340
Description
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 GSK’s Clinical Study Register is no longer maintained for this study.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”
Lien
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Mots-clés
Versions (2)
- 08/11/2017 08/11/2017 -
- 08/11/2017 08/11/2017 -
Détendeur de droits
Pfizer
Téléchargé le
8 novembre 2017
DOI
Pour une demande vous connecter.
Licence
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
Similar models
Workbook 1 Visit 4 Solicited Adverse Events
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
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 taken? Day 0
boolean
Fever
Item
Fever taken? Day 1
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 1
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 2
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 2
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 3
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 3
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 4
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 4
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 5
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 5
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 6
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 6
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 7
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 7
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])
Causality
Item
Causality?
boolean
C0015127 (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])
Item
Medically attended visit
text
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])
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Irritability/fussiness Day 1
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Irritability/fussiness Day 2
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of irritability/fussiness day 3
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of irritability/fussiness day 4
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of irritability/fussiness Day 5
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of irritability/fussiness Day 6
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of irritability/fussiness Day 7
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (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])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,2])
Item
Medically attended visit Type
text
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])
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
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
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of drowsiness Day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 4
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 5
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 6
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Intensity of Drowsiness Day 7
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (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])
Causality
Item
Causality
boolean
C0015127 (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])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [1,4])
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
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
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 1
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity day 2
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 3
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 4
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 5
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 6
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite, Intensity Day 7
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (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])
Causality
Item
Causality?
boolean
C0015127 (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])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,4])
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)