ID

26785

Beschreibung

Study Title Stamm: Meningococcal Infections Vaccination in children NCT00196976 Study Description Stamm: 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 GSK’s Clinical Study Register is no longer maintained for this study.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 (3)
  1. 24.10.17 24.10.17 -
  2. 26.10.17 26.10.17 -
  3. 03.11.17 03.11.17 -
Rechteinhaber

Pfizer

Hochgeladen am

24. Oktober 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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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

Englisch

Visit 1 Part 2

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 1 Part 2
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

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

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
Beschreibung

Medical History

Datentyp

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
Beschreibung

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
[10] Cutaneous Diagnosis
Beschreibung

Cutaneous Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0011900
[10] Cutaneous
Beschreibung

currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0037274
[5] Eyes Diagnosis
Beschreibung

Eye Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0011900
[5] Eyes
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0015397
[6] Ears-Nose-Throat Diagnosis
Beschreibung

Ears-Nose-Throat Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
[6] Ears-Nose-Throat
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0395797
[2] Cardiovascular Diagnosis
Beschreibung

Cardiovascular disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0011900
[2] Cardiovascular
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0007222
[3] Respiratory Diagnosis
Beschreibung

Respiratory disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0011900
[3] Respiratory
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0035204
[1] Gastrointestinal Diagnosis
Beschreibung

Gastrointestinal disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0011900
[1] Gastrointestinal
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0017178
[7] Muskuloskeletal Diagnosis
Beschreibung

Muskuloskeletal disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0011900
[7] Muskuloskeletal
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0026857
[8] Neurological Diagnosis
Beschreibung

Neurological disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0011900
[8] Neurological
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0027765
[12] Genitourinary Diagnosis
Beschreibung

Genitourinary Disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0080276
UMLS CUI [1,2]
C0011900
[12] Genitourinary
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0080276
[11] Haematology Diagnosis
Beschreibung

Haematological disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0011900
[11] Haematology
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0018939
[4] Allergies Diagnosis
Beschreibung

Hypersensitivity

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0011900
[4] Allergies
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0020517
[9] Endocrine Diagnosis
Beschreibung

Endocrine Disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
[9] Endocrine
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0014130
[99] Other (specify) Diagnosis
Beschreibung

Other Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C2359476
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C2348235
[99] Other (specify)
Beschreibung

Currentness of disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C2359476
Hib and DIPHTHERIA, TETANUS, PERTUSSIS HISTORY
Beschreibung

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?
Beschreibung

Vaccination status Hib | Vaccination Status DTP

Datentyp

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
Beschreibung

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
Beschreibung

Trade Name of Vaccination

Datentyp

text

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

Dose Number

Datentyp

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
Beschreibung

Date of vaccination

Datentyp

date

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

Investigator Use

Datentyp

text

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

Hib Disease

Datentyp

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
Beschreibung

Date of Hib Disease

Datentyp

date

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

Diphteria disease

Datentyp

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
Beschreibung

Date of Diphteria disease

Datentyp

date

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

Tetanus disease

Datentyp

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
Beschreibung

Date of Tetanus disease

Datentyp

date

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

Pertussis disease

Datentyp

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
Beschreibung

Date of Pertussis disease

Datentyp

date

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

LABORATORY TESTS; BLOOD SAMPLE

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

Blood sample

Datentyp

text

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

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Visit 1 Part 2

1 Formulare
  1. StudyEvent: ODM
    1. Visit 1 Part 2
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Cutaneous Disease
Item
[10] Cutaneous Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[10] Cutaneous
text
C0699749 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
currentness of disease
Code List
[10] Cutaneous
CL Item
Past (Past)
CL Item
Current (Current)
Eye Disease
Item
[5] Eyes Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[5] Eyes
text
C0699749 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
Currentness of disease
Code List
[5] Eyes
CL Item
Past (Past)
CL Item
Current (Current)
Ears-Nose-Throat Disease
Item
[6] Ears-Nose-Throat Diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[6] Ears-Nose-Throat
text
C0699749 (UMLS CUI [1,1])
C0395797 (UMLS CUI [1,2])
Currentness of disease
Code List
[6] Ears-Nose-Throat
CL Item
Past (Past)
CL Item
Current (Current)
Cardiovascular disorder
Item
[2] Cardiovascular Diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[2] Cardiovascular
text
C0699749 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
Currentness of disease
Code List
[2] Cardiovascular
CL Item
Past (Past)
CL Item
Current (Current)
Respiratory disorder
Item
[3] Respiratory Diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[3] Respiratory
text
C0699749 (UMLS CUI [1,1])
C0035204 (UMLS CUI [1,2])
Currentness of disease
Code List
[3] Respiratory
CL Item
Past (Past)
CL Item
Current (Current)
Gastrointestinal disorder
Item
[1] Gastrointestinal Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[1] Gastrointestinal
text
C0699749 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
Currentness of disease
Code List
[1] Gastrointestinal
CL Item
Past (Past)
CL Item
Current (Current)
Muskuloskeletal disorder
Item
[7] Muskuloskeletal Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[7] Muskuloskeletal
text
C0699749 (UMLS CUI [1,1])
C0026857 (UMLS CUI [1,2])
Currentness of disease
Code List
[7] Muskuloskeletal
CL Item
Past (Past)
CL Item
Current (Current)
Neurological disorder
Item
[8] Neurological Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[8] Neurological
text
C0699749 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Currentness of disease
Code List
[8] Neurological
CL Item
Past (Past)
CL Item
Current (Current)
Genitourinary Disorder
Item
[12] Genitourinary Diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[12] Genitourinary
text
C0699749 (UMLS CUI [1,1])
C0080276 (UMLS CUI [1,2])
Currentness of disease
Code List
[12] Genitourinary
CL Item
Past (Past)
CL Item
Current (Current)
Haematological disease
Item
[11] Haematology Diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[11] Haematology
text
C0699749 (UMLS CUI [1,1])
C0018939 (UMLS CUI [1,2])
Currentness of disease
Code List
[11] Haematology
CL Item
Past (Past)
CL Item
Current (Current)
Hypersensitivity
Item
[4] Allergies Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[4] Allergies
text
C0699749 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Currentness of disease
Code List
[4] Allergies
CL Item
Past (Past)
CL Item
Current (Current)
Endocrine Disorder
Item
[9] Endocrine Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
[9] Endocrine
text
C0699749 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
Currentness of disease
Code List
[9] Endocrine
CL Item
Past (Past)
CL Item
Current (Current)
Other Diagnosis
Item
[99] Other (specify) Diagnosis
text
C2359476 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
[99] Other (specify)
text
C0699749 (UMLS CUI [1,1])
C2359476 (UMLS CUI [1,2])
Currentness of disease
Code List
[99] Other (specify)
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)
Item
Has a blood sample been taken ?
text
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
Blood sample
Code List
Has a blood sample been taken ?
CL Item
Yes (Yes)
CL Item
No (No)
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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