Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age

Phase 2

Completed

• Conditions: Influenza, Human

• Registration Number: NCT05501561
• Lead Sponsor: Seqirus

Brief Summary

This Phase 2, randomized, observer-blind, dose-confirmation Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects are to be randomized into 1 of 4 possible treatment groups with 250 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 serology data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Study Start: 2022-08-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Disposition First Posted: 2023-04-21
• Status Verified: 2024-03
• Disposition First Submitted: 2024-03-28
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1056

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

1. Individuals ≥50 years of age on the day of informed consent.

2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.

3. Individuals who can comply with study procedures including follow-up .

4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.

Exclusion Criteria

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:

1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination.

2. Progressive, unstable or uncontrolled clinical conditions.

3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.

4. History of any medical condition considered an adverse event of special interest (AESI).

5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.

7. Abnormal function of the immune system resulting from:

   1. Clinical conditions.
   2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.
   3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.

9. Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent.

10. Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination

11. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines.

12. Study personnel or immediate family or household member of study personnel.

13. Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the study period.

14. Acute (severe) febrile illness,

15. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)	180 days post-vaccination
Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains	28 days post-vaccination
The Percentage of Subjects with Unsolicited Adverse Events	28 days post-vaccination
The Percentage of Subjects with Solicited Local and Systemic Reactions	7 days post-vaccination

Secondary Outcome Measures

Name	Time	Method
Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains	28 days post-vaccination

Trial Locations

Locations (41)

Velocity Clinical Research - Medford; 🇺🇸 Medford, Oregon, United States

Clinical Research Consulting, LLC; 🇺🇸 Milford, Connecticut, United States

Meridian Clinical Research (Binghamton, NY); 🇺🇸 Binghamton, New York, United States

AMR El Dorado; 🇺🇸 El Dorado, Kansas, United States

CenExel RCA; 🇺🇸 Hollywood, Florida, United States

Meridian Clinical Research - Savannah; 🇺🇸 Savannah, Georgia, United States

Precision Clinical Research; 🇺🇸 Sunrise, Florida, United States

DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Meridian Clinical Research - Dakota Dunes; 🇺🇸 Dakota Dunes, South Dakota, United States

Velocity Clinical Research - Syracuse; 🇺🇸 Syracuse, New York, United States

AMR Lexington; 🇺🇸 Lexington, Kentucky, United States

MedPharmics LLC; 🇺🇸 Biloxi, Mississippi, United States

CVS pharmacy - Charlottesville; 🇺🇸 Charlottesville, Virginia, United States

Medpharmics, LLC; 🇺🇸 Metairie, Louisiana, United States

CVS pharmacy - Reston; 🇺🇸 Reston, Virginia, United States

Velocity Clinical Research, Spartanburg; 🇺🇸 Spartanburg, South Carolina, United States

AMR Coastal Clinical Research; 🇺🇸 Knoxville, Tennessee, United States

Rockville Internal Medicine Group; 🇺🇸 Rockville, Maryland, United States

Alliance for Multispecialty Research, LLC, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Aventiv Research, Inc. Columbus; 🇺🇸 Columbus, Ohio, United States

Marvel Clinical Research; 🇺🇸 Huntington Beach, California, United States

AMR Tempe; 🇺🇸 Tempe, Arizona, United States

The Lynn Institute of The Rockies; 🇺🇸 Colorado Springs, Colorado, United States

Innovative Research of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

Health Awareness INC; 🇺🇸 Jupiter, Florida, United States

Platinum Research Network, LLC; 🇺🇸 Savannah, Georgia, United States

Meridian Clinical Research; 🇺🇸 Grand Island, Nebraska, United States

Sundance Clinical Research, LLC; 🇺🇸 Saint Louis, Missouri, United States

Healthcare Research Network; 🇺🇸 Hazelwood, Missouri, United States

M3 Wake Research, Inc.; 🇺🇸 Raleigh, North Carolina, United States

Velocity Clinical Research, Gaffney; 🇺🇸 Gaffney, South Carolina, United States

Velocity Clinical Research - Greenville; 🇺🇸 Greenville, South Carolina, United States

Velocity Clinical Research - West Jordan; 🇺🇸 West Jordan, Utah, United States

California Research Center; 🇺🇸 San Diego, California, United States

Meridian Clinical Research, LLC; 🇺🇸 Cincinnati, Ohio, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Global Health Research Center; 🇺🇸 Tampa, Florida, United States

Velocity Clinical Research - New Smyrna Beach; 🇺🇸 Edgewater, Florida, United States

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

CVS pharmacy - Richmond; 🇺🇸 Richmond, Virginia, United States