ID
27343
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 GSK’s Clinical Study Register is no longer maintained for this study.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 3 – 5 years of age”
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Keywords
Versions (1)
- 11/8/17 11/8/17 -
Copyright Holder
Pfizer
Uploaded on
November 8, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 2 Visit 3 Part 2
- StudyEvent: ODM
Description
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0031809
Description
Medical History
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2,1]
- C0205476
- UMLS CUI [2,2]
- C0348080
- UMLS CUI [3]
- C1457887
Description
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0031809
Description
Organ system
Data type
integer
Alias
- UMLS CUI [1]
- C0678852
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
currentness of disease
Data type
text
Alias
- UMLS CUI [1,1]
- C0699749
- UMLS CUI [1,2]
- C0037274
Description
Vaccine History
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0262926
Description
undefined item
Data type
text
Alias
- UMLS CUI [1,1]
- C1443394
- UMLS CUI [1,2]
- C0700144
- UMLS CUI [1,3]
- C0042210
- UMLS CUI [1,4]
- C1517586
Description
Vaccine History
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0262926
Description
Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0042210
Description
Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Description
Investigator Use
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Description
Medication History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0013227
Description
Change of medication
Data type
text
Alias
- UMLS CUI [1]
- C0580105
Description
Medication history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0013227
Description
Name
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Medical indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Medical indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Total daily dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Ongoing medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Investigator use
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Description
LABORATORY TESTS; BLOOD SAMPLE
Alias
- UMLS CUI-1
- C0022885
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Workbook 2 Visit 3 Part 2
- StudyEvent: ODM
C0031809 (UMLS CUI-3)
C0205476 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3])
C0031809 (UMLS CUI-3)
C0037274 (UMLS CUI [1,2])
C0700144 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1517586 (UMLS CUI [1,4])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C1277698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])