ID
27343
Beschrijving
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Trefwoorden
Versies (1)
- 08-11-17 08-11-17 -
Houder van rechten
Pfizer
Geüploaded op
8 november 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 2 Visit 3 Part 2
- StudyEvent: ODM
Beschrijving
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0031809
Beschrijving
Medical History
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2,1]
- C0205476
- UMLS CUI [2,2]
- C0348080
- UMLS CUI [3]
- C1457887
Beschrijving
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-3
- C0031809
Beschrijving
Organ system
Datatype
integer
Alias
- UMLS CUI [1]
- C0678852
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
currentness of disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0699749
- UMLS CUI [1,2]
- C0037274
Beschrijving
Vaccine History
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0262926
Beschrijving
undefined item
Datatype
text
Alias
- UMLS CUI [1,1]
- C1443394
- UMLS CUI [1,2]
- C0700144
- UMLS CUI [1,3]
- C0042210
- UMLS CUI [1,4]
- C1517586
Beschrijving
Vaccine History
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0262926
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0042210
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Beschrijving
Investigator Use
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Beschrijving
Medication History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0013227
Beschrijving
Change of medication
Datatype
text
Alias
- UMLS CUI [1]
- C0580105
Beschrijving
Medication history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0013227
Beschrijving
Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Medical indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Medical indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Investigator use
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Beschrijving
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])