ID
27337
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 GSK’s Clinical Study Register is no longer maintained for this study.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 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)
- 2017-11-08 2017-11-08 -
- 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 Non-Serious Adverse Events
- StudyEvent: ODM
Beskrivning
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-serious adverse event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Adverse event Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beskrivning
Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beskrivning
Location
Datatyp
text
Alias
- UMLS CUI [1]
- C0450429
Beskrivning
Investigator Use
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Beskrivning
Start date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Date started
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End date
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Relationship to investigational product
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0013230
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1518404
Beskrivning
Medically attended visit Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1386497
- UMLS CUI [1,4]
- C1518404
Similar models
Workbook 1 Non-Serious Adverse Events
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])