ID
27341
Beschreibung
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 GSK’s Clinical Study Register is no longer maintained for this study.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
Stichworte
Versionen (2)
- 04.11.17 04.11.17 -
- 08.11.17 08.11.17 -
Rechteinhaber
Pfizer
Hochgeladen am
8. November 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976
Workbook 1 Visit 4 Part 1
- StudyEvent: ODM
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Use of investigational new drug
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1524063
Beschreibung
Immunosuppressants | Immune-modifying drugs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2,1]
- C0005525
- UMLS CUI [2,2]
- C0205191
Beschreibung
Meningococcal vaccine
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0700144
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beschreibung
Other vaccine
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Beschreibung
Immunoglobulins | Blood products
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Beschreibung
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Alias
- UMLS CUI-1
- C0522473
- UMLS CUI-2
- C0042196
Beschreibung
undefined item
Datentyp
text
Beschreibung
Anaphylactic reaction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0042196
Beschreibung
undefined item
Datentyp
text
Beschreibung
Acute illness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4061114
Beschreibung
Fever
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
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
Beschreibung
Hypersensitivity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0042210
Beschreibung
central nervous system disorder
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0007682
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschreibung
Fever
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschreibung
Collapse | Shock-like state
Datentyp
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
Beschreibung
Persistent Crying
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2721683
- UMLS CUI [1,2]
- C1510821
- UMLS CUI [1,3]
- C0042210
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Center Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
undefined item
Datentyp
text
Beschreibung
undefined item
Datentyp
text
Beschreibung
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Number of SAE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Ähnliche Modelle
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])