ID
27341
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 GSK’s Clinical Study Register is no longer maintained for this study.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 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”
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Trefwoorden
Versies (2)
- 04-11-17 04-11-17 -
- 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 1 Visit 4 Part 1
- StudyEvent: ODM
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Use of investigational new drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1524063
Beschrijving
Immunosuppressants | Immune-modifying drugs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2,1]
- C0005525
- UMLS CUI [2,2]
- C0205191
Beschrijving
Meningococcal vaccine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0700144
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beschrijving
Other vaccine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beschrijving
Immunoglobulins | Blood products
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Beschrijving
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Alias
- UMLS CUI-1
- C0522473
- UMLS CUI-2
- C0042196
Beschrijving
undefined item
Datatype
text
Beschrijving
Anaphylactic reaction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0042196
Beschrijving
undefined item
Datatype
text
Beschrijving
Acute illness
Datatype
boolean
Alias
- UMLS CUI [1]
- C4061114
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
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
Beschrijving
Hypersensitivity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0042210
Beschrijving
central nervous system disorder
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007682
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschrijving
Collapse | Shock-like state
Datatype
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
Beschrijving
Persistent Crying
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2721683
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Center Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
undefined item
Datatype
text
Beschrijving
undefined item
Datatype
text
Beschrijving
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious adverse Event
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Number of SAE
Datatype
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])