Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
NCT ID: NCT00996138
Last Updated: 2016-12-01
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/PHASE3
200 participants
INTERVENTIONAL
2009-09-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Arm 1
Dose ranging
Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines
Arm 2
Dose ranging
Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines
Interventions
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Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
* Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
* History of progressive or severe neurological disorders
29 Years
60 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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Osaka pref.
Kagoshima Pref., , Japan
Countries
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References
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Fukase H, Furuie H, Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Yotsuyanagi H, Kusadokoro H, Sawata H, Nakura N, Lattanzi M. Assessment of the immunogenicity and safety of varying doses of an MF59(R)-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects. Vaccine. 2012 Jul 13;30(33):5030-7. doi: 10.1016/j.vaccine.2012.03.053. Epub 2012 Apr 1.
Other Identifiers
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V110_05
Identifier Type: -
Identifier Source: org_study_id
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