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

Status: Completed
Location: See all (18) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Subjects who received 2 doses of aH5N1c vaccine or placebo in and completed the parent study V89\_18 in the \<65 years of age cohort.

• Individuals who can comply with study procedures including follow-up.

Locations
United States
Alabama
Optimal Research, LLC
Huntsville
Arizona
Clinical Research Consortium Arizona
Tempe
California
California Research Foundation
San Diego
Connecticut
Clinical Research Consulting, LLC
Milford
Florida
Innovative Research of West Florida, Inc.
Clearwater
Optimal Research, LLC
Melbourne
Illinois
Great Lakes Clinical Trials LLC
Chicago
Kansas
Heartland Research Associates, LLC
Wichita
Missouri
The Center for Pharmaceutical Research
Kansas City
Sundance Clinical Research, LLC
St Louis
North Carolina
PMG Research of Raleigh
Raleigh
AccellaCare
Winston-salem
New York
Rochester Clinical Research, Inc
Rochester
Ohio
Aventiv Research
Columbus
Texas
Biogenics Research Institute
San Antonio
Utah
J. Lewis Research, Inc/Foothill Family Clinic North
Salt Lake City
J. Lewis Research, Inc/Foothill Family Clinic South
Salt Lake City
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan
Time Frame
Start Date: 2022-07-18
Completion Date: 2023-03-24
Participants
Target number of participants: 260
Treatments
Experimental: Group 1
Eligible subjects who received 2 doses of aH5N1c in the parent study V89\_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart
Experimental: Group 2
Eligible subjects who received 2 doses of aH5N1c in the parent study V89\_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22
Experimental: Group 3
Eligible subjects who received placebo in the parent study V89\_18 receive two aH5N6c vaccinations, 3 weeks apart.
Related Therapeutic Areas
Sponsors
Leads: Seqirus

This content was sourced from clinicaltrials.gov