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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
July 18, 2022
Primary Completion Date
October 24, 2022
Completion Date
March 24, 2023
Last Updated
August 3, 2023
260
ACTUAL participants
aH5N6c on Day 1
BIOLOGICAL
aH5N6c on Day 22
BIOLOGICAL
Placebo on Day 22
BIOLOGICAL
Lead Sponsor
Seqirus
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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