Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Completed · Phase 3
Conditions studied: Prophylaxis: Influenza
In brief
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.
Key facts
- Study ID
- NCT02256488
- Run by
- Novartis Vaccines
- People needed
- 1561
- Starts
- 2014-09-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2019-06-11
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
You may not qualify if…
- Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
Where it is running
- Anaheim Clincial Trials — Anaheim, California, United States
- Northern California Clinical Research Center — Redding, California, United States
- Southern California CRC — San Diego, California, United States
- Broward Research Group — Hollywood, Florida, United States
- Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
- Palm Bech Research — West Palm Beach, Florida, United States
- Meridian Clinical Research — Savannah, Georgia, United States
- Johnson County Clin-Trials, LLC — Lenexa, Kansas, United States
- Heartland Research Associates, LLC — Wichita, Kansas, United States
- Milford Emergency Associate,Inc — Milford, Massachusetts, United States
- Meridian Clinical Research — Omaha, Nebraska, United States
- Rochester Clinical Research, Inc — Rochester, New York, United States
- PMG Research of Charlotte — Charlotte, North Carolina, United States
- PMG Research of Hickory — Hickory, North Carolina, United States
- PMG Research of Raleigh — Raleigh, North Carolina, United States
- New Horizons Clinical Research — Cincinnati, Ohio, United States
- Columbia Research Group, Inc — Portland, Oregon, United States
- Omega Medical Research — Warwick, Rhode Island, United States
- Clinical Research Solutions, LLC — Franklin, Tennessee, United States
- Clinical Research Associates, Inc — Nashville, Tennessee, United States
- Foothill Family Clinc South, J. Lewis Research Inc. — Salt Lake City, Utah, United States
- Foothill Family Clinic, J. Lewis Research Inc. — Salt Lake City, Utah, United States
- Jordan River Family Medicine, J. Lewis Research, Inc. — South Jordan, Utah, United States
- Clinical Research Associates — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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