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Influenza, Human

A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
NCT05422326 | PHASE 2 | INTERVENTIONAL

This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the \<65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are moni

Trial Information
18 Sites
260 Participants
Recruiting
18 Years to 65 Years

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Optimal Research, LLC
Huntsville,Alabama,United States,35802
Clinical Research Consortium Arizona
Tempe,Arizona,United States,85283
California Research Foundation
San Diego,California,United States,92103
Clinical Research Consulting, LLC
Milford,Connecticut,United States,06460
Innovative Research of West Florida, Inc.
Clearwater,Florida,United States,33756
Optimal Research, LLC
Melbourne,Florida,United States,32934
Great Lakes Clinical Trials LLC
Chicago,Illinois,United States,60640
Heartland Research Associates, LLC
Wichita,Kansas,United States,67207
The Center for Pharmaceutical Research
Kansas City,Missouri,United States,64114
Sundance Clinical Research, LLC
Saint Louis,Missouri,United States,63141
Rochester Clinical Research, Inc
Rochester,New York,United States,14609
PMG Research of Raleigh
Raleigh,North Carolina,United States,27609
AccellaCare
Winston-Salem,North Carolina,United States,27103
Aventiv Research
Columbus,Ohio,United States,43213
Biogenics Research Institute
San Antonio,Texas,United States,78229
J. Lewis Research, IncFoothill Family Clinic North
Salt Lake City,Utah,United States,84109
J. Lewis Research, IncFoothill Family Clinic South
Salt Lake City,Utah,United States,84121
J. Lewis Research, IncJordan River Family Medicine
South Jordan,Utah,United States,84095

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov