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COMPLETED
NCT05422326
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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)

BIOLOGICAL

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

BIOLOGICAL

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