ID
27341
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 GSK’s Clinical Study Register is no longer maintained for this study.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 12 – 14 months of age”
Länk
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Nyckelord
Versioner (2)
- 2017-11-04 2017-11-04 -
- 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 1 Visit 4 Part 1
- StudyEvent: ODM
Beskrivning
Exclusion Criteria
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
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Alias
- UMLS CUI-1
- C0522473
- UMLS CUI-2
- C0042196
Beskrivning
undefined item
Datatyp
text
Beskrivning
Anaphylactic reaction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0042196
Beskrivning
undefined item
Datatyp
text
Beskrivning
Acute illness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4061114
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Contraindications to the administration of GSK Biologicals’ DTPa-IPV/Hib vaccine (INFANRIX™ - IPV/HIB) and to GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (INFANRIX™ HEXA)
Alias
- UMLS CUI-1
- C0522473
Beskrivning
Hypersensitivity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0042210
Beskrivning
central nervous system disorder
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0007682
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beskrivning
Fever
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beskrivning
Collapse | Shock-like state
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344329
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
- UMLS CUI [2,1]
- C0036974
- UMLS CUI [2,2]
- C1510821
- UMLS CUI [2,3]
- C0042210
Beskrivning
Persistent Crying
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2721683
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Center Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
undefined item
Datatyp
text
Beskrivning
undefined item
Datatyp
text
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 1 Visit 4 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])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2,1])
C1510821 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])