Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
NCT ID: NCT00973349
Last Updated: 2015-12-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
2719 participants
INTERVENTIONAL
2009-09-30
2010-12-31
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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3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Interventions
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MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
* Known or suspected impairment/alteration of immune function.
* Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
* Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
* For additional entry criteria, please refer to protocol.
18 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccine and Diagnostics
Role: STUDY_DIRECTOR
Novartis
Locations
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Miami Research Associates
Miami, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Meridien Clinical Research
Omaha, Nebraska, United States
Regional Clinical Research
Endwell, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Triangle Medical Research Associates
Cary, North Carolina, United States
Triangle Medical Research Associates
Raleigh, North Carolina, United States
Carolina Medical Trials
Winston-Salem, North Carolina, United States
Prestige Clinical Research
Franklin, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
West Ridge Family Practice (adult)
Erie, Pennsylvania, United States
Primary Physicians Research Inc. (adult)
Jefferson Hills, Pennsylvania, United States
Omega Clinical Research
Warwick, Rhode Island, United States
Research Across America
Dallas, Texas, United States
West Houston Clinical Research Service
Houston, Texas, United States
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, United States
PI-Coor Clinical Research
Burke, Virginia, United States
PI Coor Clinical Research
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Instituto Nacional de Ciencias
Tlalpan, , Mexico
Countries
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Other Identifiers
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V112_01
Identifier Type: -
Identifier Source: org_study_id