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ID
26785
Description
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Keywords
Versions (3)
- 10/24/17 10/24/17 -
- 10/26/17 10/26/17 -
- 11/3/17 11/3/17 -
Copyright Holder
Pfizer
Uploaded on
October 24, 2017
DOI
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License
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
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Visit 1 Part 2
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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)
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])
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)
C0031809 (UMLS CUI-3)
Cutaneous Disease
Item
[10] Cutaneous Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[6] Ears-Nose-Throat
text
C0699749 (UMLS CUI [1,1])
C0395797 (UMLS CUI [1,2])
C0395797 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[2] Cardiovascular
text
C0699749 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C0007222 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[3] Respiratory
text
C0699749 (UMLS CUI [1,1])
C0035204 (UMLS CUI [1,2])
C0035204 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[1] Gastrointestinal
text
C0699749 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[7] Muskuloskeletal
text
C0699749 (UMLS CUI [1,1])
C0026857 (UMLS CUI [1,2])
C0026857 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[8] Neurological
text
C0699749 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0027765 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[12] Genitourinary
text
C0699749 (UMLS CUI [1,1])
C0080276 (UMLS CUI [1,2])
C0080276 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
Item
[11] Haematology
text
C0699749 (UMLS CUI [1,1])
C0018939 (UMLS CUI [1,2])
C0018939 (UMLS CUI [1,2])
CL Item
Past (Past)
CL Item
Current (Current)
Hypersensitivity
Item
[4] Allergies Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
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])
C0011900 (UMLS CUI [1,2])
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])
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])
C2359476 (UMLS CUI [1,2])
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)
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])
C0199818 (UMLS CUI [1,2])
C1443394 (UMLS CUI [2,1])
C0012559 (UMLS CUI [2,2])
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)
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])
C0042210 (UMLS CUI [1,2])
Dose Number
Item
Dose Number of Vaccination
text
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
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])
C0042196 (UMLS CUI [1,2])
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
Item
Previous history of Hib disease:
text
C2028293 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
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])
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])
C3714514 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
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])
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])
C0262926 (UMLS CUI [1,2])
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])
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])
C0262926 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
Item
Has a blood sample been taken ?
text
C0005834 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])