Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Completed · Phase 2/Phase 3

Conditions studied: Influenza

In brief

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Key facts

Study ID

NCT00973349

Run by

Novartis

People needed

2719

Starts

2009-09-01

Expected to finish

2010-12-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

You may not qualify if…

• History of serious disease.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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