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
Public ClinicalTrials.gov record NCT05422326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05422326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 260 participants
Conditions and interventions
Conditions
Interventions
- aH5N6c on Day 1 Biological
- aH5N6c on Day 22 Biological
- Placebo on Day 22 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 17, 2022
- Primary completion
- Oct 23, 2022
- Completion
- Mar 23, 2023
- Last update posted
- May 12, 2026
2022 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Research, LLC | Huntsville | Alabama | 35802 | — |
| Clinical Research Consortium Arizona | Tempe | Arizona | 85283 | — |
| California Research Foundation | San Diego | California | 92103 | — |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Optimal Research, LLC | Melbourne | Florida | 32934 | — |
| Great Lakes Clinical Trials LLC | Chicago | Illinois | 60640 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | — |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | — |
| AccellaCare | Winston-Salem | North Carolina | 27103 | — |
| Aventiv Research | Columbus | Ohio | 43213 | — |
| Biogenics Research Institute | San Antonio | Texas | 78229 | — |
| J. Lewis Research, Inc/Foothill Family Clinic North | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| J. Lewis Research, Inc/Jordan River Family Medicine | South Jordan | Utah | 84095 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05422326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05422326 live on ClinicalTrials.gov.