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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
Sponsor: Seqirus
Summary
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 monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.
Official title: A Phase 2, Randomized, Study to Evaluate Safety and Immunogenicity of One or Two Heterologous Booster Vaccinations With an MF59-adjuvanted, Cell Culture-derived H5N6 Influenza Vaccine in Adults Primed With MF59-adjuvanted, Cell Culture-derived H5N1 Influenza Vaccine or Unprimed
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2022-07-18
Completion Date
2023-03-24
Last Updated
2026-05-13
Healthy Volunteers
Yes
Conditions
Interventions
aH5N6c on Day 1
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 μg H5N6 hemagglutinin (HA) (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume)
aH5N6c on Day 22
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 μg H5N6 HA (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume) given 3 weeks after the first aH5N6c vaccination
Placebo on Day 22
Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination
Locations (18)
Optimal Research, LLC
Huntsville, Alabama, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
California Research Foundation
San Diego, California, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Optimal Research, LLC
Melbourne, Florida, United States
Great Lakes Clinical Trials LLC
Chicago, Illinois, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
AccellaCare
Winston-Salem, North Carolina, United States
Aventiv Research
Columbus, Ohio, United States
Biogenics Research Institute
San Antonio, Texas, United States
J. Lewis Research, Inc/Foothill Family Clinic North
Salt Lake City, Utah, United States
J. Lewis Research, Inc/Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, United States