Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Public ClinicalTrials.gov record NCT04576702. 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, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.
Study identification
- NCT ID
- NCT04576702
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 471 participants
Conditions and interventions
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
- Oct 7, 2020
- Primary completion
- Mar 18, 2021
- Completion
- May 23, 2021
- Last update posted
- Apr 16, 2024
2020 – 2021
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 4022 - Coastal Clinical Research, an AMR company | Mobile | Alabama | 36608 | — |
| 4002 - Clinical Research Consortium, an AMR company | Tempe | Arizona | 85283 | — |
| 4006 - Westside Center for Clinical Research | Jacksonville | Florida | 32205 | — |
| 4013 - Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| 4021 - Research Centers of America, LLC | Oakland | Florida | 33334 | — |
| 4023 - Advanced Clinical Research | Boise | Idaho | 83642 | — |
| 4010 - Heartland Research Associates, LLC | Newton | Kansas | 67114 | — |
| 4016 - Heartland Research Associates, LLC - An AMR Company | Wichita | Kansas | 67207 | — |
| 4001 - Central Kentucky Research Associates, an AMR company | Lexington | Kentucky | 40509 | — |
| 4014 - Medpharmi | Kenner | Louisiana | 70065 | — |
| 4008 - The Center for Pharmaceutical Research, an AMR company | Kansas City | Missouri | 64114 | — |
| 4024 - Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| 4009 - Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| 4007 - Regional Clinical Research / United Medical Associates | Binghamton | New York | 13901 | — |
| 4012 - M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| 4004 - Sterling research | Cincinnati | Ohio | 45219 | — |
| 4017 - Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| 4011 - Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| 4005 - Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| 4018 - Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
| 4020 - Advanced Clinical Research | West Jordan | Utah | 84088 | — |
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 NCT04576702, 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 Apr 16, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04576702 live on ClinicalTrials.gov.