Vero cell derived, trivalent, seasonal influenza vaccine
BiologicalSingle intramuscular injection
NCT Number: NCT00782431
The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition [HI] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.
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Notify Me50 year and older
All sexes
Interventional
Phase 3
Coastal Clinical Research, Inc., Mobile, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single intramuscular injection
Single intramuscular injection
Time frame: 21 days
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer < 10) at baseline.
Time frame: 21 days
The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.
Time frame: 21 days
Time frame: 21 days
Change in geometric mean of titers at day 21 compared to baseline
Time frame: 21 days
Time frame: 21 days
Time frame: 180 days
Alachua Government Services, Inc.
Industry
Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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