Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
NCT ID: NCT01357265
Last Updated: 2011-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
125 participants
INTERVENTIONAL
2011-05-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Seasonal Influenza Vaccine
This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Interventions
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Seasonal Influenza Vaccine
This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Cheiti, Italy
Dipartimento di Scienze della Salute Università di Genova
Via Pastore, Genova, Italy
Distretto Sanitario di Base di Fossacesia
Via Polidoro-Vasto, Lanciano, Italy
ASL Lanciano - Vasto,
Via S. Spaventa, Lanciano, Italy
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
Via Stamira d'Ancona, Milano, Italy
Dipartimento di malattie infettive Ospedale San Gerardo
Via Pergolesi 33, Monza, Italy
Countries
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Other Identifiers
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2010-024400-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V71_27S
Identifier Type: -
Identifier Source: org_study_id