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
NCT ID: NCT05422326
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2022-07-18
2023-03-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Eligible subjects, who received placebo in the parent study are allocated to group 3 (two aH5N6c vaccinations, 3 weeks apart).
PREVENTION
TRIPLE
Study Groups
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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
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
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
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)
Placebo on Day 22
Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination
Group 3
Eligible subjects who received placebo in the parent study V89\_18 receive two aH5N6c vaccinations, 3 weeks apart.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Individuals who can comply with study procedures including follow-up.
Exclusion Criteria
* Progressive, unstable or uncontrolled clinical conditions.
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system.
* History of any medical condition considered an adverse event of special interest (AESI).
* Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent.
* Subjects, who received an influenza H5 vaccine other than in the V89\_18 parent study or have a history of H5 influenza infection prior to enrollment.
* Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
* Individuals who received any other vaccines \[except corona virus disease 2019 (COVID-19) vaccines\] within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
* Receipt of any COVID-19 vaccine within 7 days prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination.
* Acute (severe) febrile illness.
* A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
18 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Therapeutic Area Head
Role: STUDY_CHAIR
Seqirus
Locations
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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
Countries
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Other Identifiers
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V89_18E1
Identifier Type: -
Identifier Source: org_study_id
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