Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
Public ClinicalTrials.gov record NCT05501561. 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 2b, Randomized, Observer-Blind, Antigen and Adjuvant Dose-Confirmation Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.
Study identification
- NCT ID
- NCT05501561
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,056 participants
Conditions and interventions
Conditions
Interventions
- Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1 Biological
- Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1 Biological
- Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1 Biological
- Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1 Biological
Biological
Eligibility (public fields only)
- Age range
- 50 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
- Aug 25, 2022 (Actual)
- Primary completion
- Mar 31, 2023 (Actual)
- Completion
- Mar 31, 2023 (Actual)
- Last update posted
- Jun 30, 2026
2022 – 2023
United States locations
- U.S. sites
- 47
- U.S. states
- 25
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AMR Tempe | Tempe | Arizona | 85281 | — |
| Marvel Clinical Research | Huntington Beach | California | 92647 | — |
| California Research Center | San Diego | California | 92123 | — |
| The Lynn Institute of The Rockies | Colorado Springs | Colorado | 80920 | — |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Velocity Clinical Research - New Smyrna Beach | Edgewater | Florida | 32132 | — |
| CenExel RCA | Hollywood | Florida | 33024 | — |
| Health Awareness INC | Jupiter | Florida | 33458 | — |
| Global Health Research Center | Miami Lakes | Florida | 33016 | — |
| Precision Clinical Research | Sunrise | Florida | 33351 | — |
| Global Health Research Center | Tampa | Florida | 33615 | — |
| Platinum Research Network, LLC | Savannah | Georgia | 31405 | — |
| Meridian Clinical Research - Savannah | Savannah | Georgia | 31406 | — |
| AMR El Dorado | El Dorado | Kansas | 67042 | — |
| AMR Lexington | Lexington | Kentucky | 40509 | — |
| Meridian Clinical Research | Baton Rouge | Louisiana | 70808 | — |
| Medpharmics, LLC | Metairie | Louisiana | 70006 | — |
| Rockville Internal Medicine Group | Rockville | Maryland | 20854 | — |
| MedPharmics LLC | Biloxi | Mississippi | 39531 | — |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research | Bellevue | Nebraska | 68005 | — |
| Meridian Clinical Research | Grand Island | Nebraska | 68803 | — |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | — |
| Alliance for Multispecialty Research, LLC, Las Vegas | Las Vegas | Nevada | 89119 | — |
| Meridian Clinical Research (Binghamton, NY) | Binghamton | New York | 13901 | — |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | — |
| Velocity Clinical Research - Syracuse | Syracuse | New York | 13057 | — |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45219 | — |
| Meridian Clinical Research, LLC | Cincinnati | Ohio | 45246 | — |
| Aventiv Research, Inc. Columbus | Columbus | Ohio | 43213 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | — |
| Velocity Clinical Research, Gaffney | Gaffney | South Carolina | 29340 | — |
| Velocity Clinical Research - Greenville | Greenville | South Carolina | 29615 | — |
| Velocity Clinical Research, Spartanburg | Spartanburg | South Carolina | 29303 | — |
| Meridian Clinical Research - Dakota Dunes | Dakota Dunes | South Dakota | 57049 | — |
| AMR Coastal Clinical Research | Knoxville | Tennessee | 37920 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | — |
| Velocity Clinical Research - West Jordan | West Jordan | Utah | 84088 | — |
| CVS pharmacy - Charlottesville | Charlottesville | Virginia | 22902 | — |
| CVS pharmacy - Reston | Reston | Virginia | 20190 | — |
| CVS pharmacy - Richmond | Richmond | Virginia | 23235 | — |
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 NCT05501561, 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 Jun 30, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05501561 live on ClinicalTrials.gov.