ID
27342
Beskrivning
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 GSK’s Clinical Study Register is no longer maintained for this study.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 CRF Seiten: 599-679 & 1063-1112 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” Previous study : 103533 (MenACWY-TT-010) Same subject number as previous study
Länk
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Nyckelord
Versioner (1)
- 2017-11-08 2017-11-08 -
Rättsinnehavare
Pfizer
Uppladdad den
8 november 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 2 Visit 3 Part 1
- StudyEvent: ODM
Beskrivning
Eliminiation Criteria during the study
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Use of investigational new drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1524063
Beskrivning
Immunosuppressants | Immune-modifying drugs
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2,1]
- C0005525
- UMLS CUI [2,2]
- C0205191
Beskrivning
Meningococcal vaccine
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700144
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beskrivning
Other vaccine
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beskrivning
Immunoglobulins | Blood products
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Number of SAE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Similar models
Workbook 2 Visit 3 Part 1
- StudyEvent: ODM
C1524063 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0371802 (UMLS CUI [2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])