Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
NCT ID: NCT00382187
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
40 participants
INTERVENTIONAL
2006-11-30
2008-01-31
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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MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms
MF59 adjuvanted H5N1 influenza vaccine
* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1
MF59 adjuvant H5N1 influenza vaccine 15 micrograms
MF59 adjuvanted H5N1 influenza vaccine
* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1
non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen
MF59 adjuvanted H5N1 influenza vaccine
* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1
Interventions
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MF59 adjuvanted H5N1 influenza vaccine
* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
18 Years
60 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines - Information Services
Role: STUDY_CHAIR
Novartis
Locations
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Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
Siena, Siena, Italy
Countries
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References
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Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.
Other Identifiers
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Eudract number 2006-004063-66
Identifier Type: -
Identifier Source: secondary_id
V87P2
Identifier Type: -
Identifier Source: org_study_id
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