ID

27218

Descrizione

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 GSK’s Clinical Study Register is no longer maintained for this study.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

collegamento

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Keywords

versioni (1)
  1. 03/11/17 03/11/17 -
Titolare del copyright

Pfizer

Caricato su

3 novembre 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976

Inglese

Workbook 2 Visit 1 Part 2

1 moduli  
Administrative Documentation
Descrizione

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Descrizione

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ? Please tick appropriate box(es) and give diagnosis
Descrizione

Medical History

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2,1]
C0205476
UMLS CUI [2,2]
C0348080
UMLS CUI [3]
C1457887
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Descrizione

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Organ system
Descrizione

Organ system

Tipo di dati

integer

Alias
UMLS CUI [1]
C0678852
Ongoing disease?
Descrizione

currentness of disease

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0037274
Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY
Descrizione

Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0121772
UMLS CUI-4
C0262926
UMLS CUI-5
C0012546
UMLS CUI-7
C0262926
UMLS CUI-8
C0039614
UMLS CUI-10
C0262926
UMLS CUI-11
C0043167
Is the subject's previous vaccination status against Hib and DTP known?
Descrizione

Vaccination status Hib | Vaccination Status DTP

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1443394
UMLS CUI [1,2]
C0199818
UMLS CUI [2,1]
C1443394
UMLS CUI [2,2]
C0012559
Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY
Descrizione

Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0121772
UMLS CUI-3
C0262926
UMLS CUI-4
C0012546
UMLS CUI-5
C0262926
UMLS CUI-6
C0039614
UMLS CUI-7
C0262926
UMLS CUI-8
C0043167
Trade / Generic Name of Vaccination
Descrizione

Trade Name of Vaccination

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Dose Number of Vaccination
Descrizione

Dose Number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
Estimated date of vaccine* * Enter approximate date in case the exact date is unknown
Descrizione

Date of vaccination

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
For GSK
Descrizione

Investigator Use

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457083
Previous history of Hib disease:
Descrizione

Hib Disease

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2028293
UMLS CUI [1,2]
C0262926
Previous history of Hib disease: Estimated date* * Enter approximate date in case the exact date is unknown
Descrizione

Date of Hib Disease

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2028293
UMLS CUI [1,2]
C0011008
Previous history of diphtheria disease:
Descrizione

Diphteria disease

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0012546
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0262926
Previous history of diphtheria disease: Estimated date* * Enter approximate date in case the exact date is unknown
Descrizione

Date of Diphteria disease

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0012546
UMLS CUI [1,3]
C3714514
Previous history of tetanus disease:
Descrizione

Tetanus disease

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0039614
UMLS CUI [1,2]
C0262926
Previous history of tetanus disease: Estimated date* * Enter approximate date in case the exact date is unknown
Descrizione

Date of Tetanus disease

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0039614
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0011008
Previous history of pertussis disease:
Descrizione

Pertussis disease

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0043167
UMLS CUI [1,2]
C0262926
Previous history of pertussis disease: Estimated date* * Enter approximate date in case the exact date is unknown
Descrizione

Date of Pertussis disease

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0043167
UMLS CUI [1,2]
C0011008
LABORATORY TESTS; BLOOD SAMPLE
Descrizione

LABORATORY TESTS; BLOOD SAMPLE

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken ?
Descrizione

Blood sample

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1277698
Please complete only if different from visit date:
Descrizione

Date of blood sample

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Workbook 2 Visit 1 Part 2

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Medical History
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study ? Please tick appropriate box(es) and give diagnosis
boolean
C0262926 (UMLS CUI [1])
C0205476 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3])
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Item
Organ system
integer
C0678852 (UMLS CUI [1])
Organ system
Code List
Organ system
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (12)
CL Item
Haematology  (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
Item
Ongoing disease?
text
C0699749 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
currentness of disease
Code List
Ongoing disease?
CL Item
Past (Past)
CL Item
Current (Current)
Item Group
Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY
C0262926 (UMLS CUI-1)
C0121772 (UMLS CUI-2)
C0262926 (UMLS CUI-4)
C0012546 (UMLS CUI-5)
C0262926 (UMLS CUI-7)
C0039614 (UMLS CUI-8)
C0262926 (UMLS CUI-10)
C0043167 (UMLS CUI-11)
Item
Is the subject's previous vaccination status against Hib and DTP known?
text
C1443394 (UMLS CUI [1,1])
C0199818 (UMLS CUI [1,2])
C1443394 (UMLS CUI [2,1])
C0012559 (UMLS CUI [2,2])
Vaccination status Hib | Vaccination Status DTP
Code List
Is the subject's previous vaccination status against Hib and DTP known?
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes, if yes, please complete the following table (Yes, if yes, please complete the following table)
Item Group
Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY
C0262926 (UMLS CUI-1)
C0121772 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0012546 (UMLS CUI-4)
C0262926 (UMLS CUI-5)
C0039614 (UMLS CUI-6)
C0262926 (UMLS CUI-7)
C0043167 (UMLS CUI-8)
Trade Name of Vaccination
Item
Trade / Generic Name of Vaccination
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Dose Number
Item
Dose Number of Vaccination
text
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date of vaccination
Item
Estimated date of vaccine* * Enter approximate date in case the exact date is unknown
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item
Previous history of Hib disease:
text
C2028293 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Hib Disease
Code List
Previous history of Hib disease:
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Please complete date(s) ) (Yes (Please complete date(s) ))
Date of Hib Disease
Item
Previous history of Hib disease: Estimated date* * Enter approximate date in case the exact date is unknown
date
C2028293 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Previous history of diphtheria disease:
text
C0012546 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Diphteria disease
Code List
Previous history of diphtheria disease:
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Please complete date(s) ) (Yes (Please complete date(s) ))
Date of Diphteria disease
Item
Previous history of diphtheria disease: Estimated date* * Enter approximate date in case the exact date is unknown
date
C0011008 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
Item
Previous history of tetanus disease:
text
C0039614 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Tetanus disease
Code List
Previous history of tetanus disease:
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Please complete date(s) ) (Yes (Please complete date(s) ))
Date of Tetanus disease
Item
Previous history of tetanus disease: Estimated date* * Enter approximate date in case the exact date is unknown
date
C0039614 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Previous history of pertussis disease:
text
C0043167 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Pertussis disease
Code List
Previous history of pertussis disease:
CL Item
No (No)
CL Item
Unknown (Unknown)
CL Item
Yes (Please complete date(s) ) (Yes (Please complete date(s) ))
Date of Pertussis disease
Item
Previous history of pertussis disease: Estimated date* * Enter approximate date in case the exact date is unknown
date
C0043167 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
LABORATORY TESTS; BLOOD SAMPLE
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Date of blood sample
Item
Please complete only if different from visit date:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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