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

NCT05501561 | Completed Phase 2 Results FDA Drug

• 1 other identifier: V201_07
• Study Type: interventional
• Target: 1,056
• Locations: 1 country
• Sites: 47

Brief Summary

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.

Conditions

Influenza, Human

Keywords

influenza, vaccine, MF59, adjuvant

Outcome Measures

Primary Outcomes (9)

• Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29

  GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives.

  Day 1 and Day 29

• Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)

  Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains.

  Day 1 to Day 29

• Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29

  Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains.

  Day 1 and Day 29

• Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)

  Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies.

  Day 1 to Day 29

• Immunogenicity Endpoint: GMT Ratio (HI Assay)

  The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group).

  Day 29

• Solicited Local or Systemic AEs

  Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary \[eDiary\]). No hypothesis testing was performed for the primary safety objectives.

  Day 1 through Day 7

• Severe Solicited Local or Systemic AEs

  Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary).

  Day 1 through Day 7

• Unsolicited AEs

  Number and percentage of subjects with unsolicited AEs for 28 days following vaccination

  Day 1 to Day 29

• Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)

  Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs

  Day 1 to Day 181

Secondary Outcomes (4)

• Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29

  Day 1 and Day 29

• Immunogenicity Endpoint: GMFI (MN Assay)

  Day 1 to Day 29

• Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)

  Day 1 to Day 29

• Immunogenicity Endpoint: GMT Ratio (MN Assay)

  Day 29

Study Arms (4)

IIV-A Investigational

EXPERIMENTAL

Biological: Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1

aIIV-B Investigational

EXPERIMENTAL

Biological: Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1

aIIV-C Investigational

EXPERIMENTAL

Biological: Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1

Licensed IIV

ACTIVE COMPARATOR

Biological: Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1

Interventions

Experimental: IIV-A Investigational IIV-A administered as a single dose intramuscularly on Day 1 BIOLOGICAL

Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine (higher hemagglutinin \[HA\] dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

IIV-A Investigational

Experimental: aIIV-B Investigational aIIV-B administered as a single dose intramuscularly on Day 1 BIOLOGICAL

Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, standard dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

aIIV-B Investigational

Experimental: aIIV-C Investigational aIIV-C administered as a single dose intramuscularly on Day 1 BIOLOGICAL

Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine (higher HA dose, higher dose MF59), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

aIIV-C Investigational

Active Comparator: Licensed IIV IIV administered as a single dose intramuscularly on Day 1 BIOLOGICAL

Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine (standard HA dose), containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

Licensed IIV

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥50 years of age on the day of informed consent.
• 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.
• Individuals who can comply with study procedures including follow-up .
• 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.

You may not qualify if:

• 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.
• Progressive, unstable or uncontrolled clinical conditions.
• Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
• History of any medical condition considered an adverse event of special interest (AESI).
• Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
• Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
• Abnormal function of the immune system resulting from:
• Clinical conditions.
• 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.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
• Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent.
• 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
• 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.
• Study personnel or immediate family or household member of study personnel.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (47)

AMR Tempe

Tempe, Arizona, 85281, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

California Research Center

San Diego, California, 92123, United States

Location

The Lynn Institute of The Rockies

Colorado Springs, Colorado, 80920, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Velocity Clinical Research - New Smyrna Beach

Edgewater, Florida, 32132, United States

Location

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Health Awareness INC

Jupiter, Florida, 33458, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Global Health Research Center

Tampa, Florida, 33615, United States

Location

Platinum Research Network, LLC

Savannah, Georgia, 31405, United States

Location

Meridian Clinical Research - Savannah

Savannah, Georgia, 31406, United States

Location

AMR El Dorado

El Dorado, Kansas, 67042, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Medpharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Rockville Internal Medicine Group

Rockville, Maryland, 20854, United States

Location

MedPharmics LLC

Biloxi, Mississippi, 39531, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Bellevue, Nebraska, 68005, United States

Location

Meridian Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research, LLC

Lincoln, Nebraska, 68510, United States

Location

Alliance for Multispecialty Research, LLC, Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Meridian Clinical Research (Binghamton, NY)

Binghamton, New York, 13901, United States

Location

Meridian Clinical Research, LLC

Endwell, New York, 13760, United States

Location

Velocity Clinical Research - Syracuse

Syracuse, New York, 13057, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45219, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45246, United States

Location

Aventiv Research, Inc. Columbus

Columbus, Ohio, 43213, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

Location

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, 29340, United States

Location

Velocity Clinical Research - Greenville

Greenville, South Carolina, 29615, United States

Location

Velocity Clinical Research, Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Meridian Clinical Research - Dakota Dunes

Dakota Dunes, South Dakota, 57049, United States

Location

AMR Coastal Clinical Research

Knoxville, Tennessee, 37920, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Velocity Clinical Research - West Jordan

West Jordan, Utah, 84088, United States

Location

CVS pharmacy - Charlottesville

Charlottesville, Virginia, 22902, United States

Location

CVS pharmacy - Reston

Reston, Virginia, 20190, United States

Location

CVS pharmacy - Richmond

Richmond, Virginia, 23235, United States

Location

Related Publications (1)

• de Looze F, Essink BJ, van Boxmeer J, Andrade C, de Rooij R, Casula D, Xing R, Tovar MP, Albano FR. Immunogenicity and safety of higher-dose cell-based adjuvanted quadrivalent influenza vaccines: Combined results of randomised, controlled dose-finding and dose-confirmation studies. Vaccine. 2026 Apr 19;79:128436. doi: 10.1016/j.vaccine.2026.128436. Epub 2026 Mar 19.

  PMID: 41855648 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Seqirus

seqirus.clinicaltrials@seqirus.com

+1 855 358 8966

Study Officials

• Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: August 25, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: SEQIRUS discloses results from clinical studies within 12 months of completion of the study unless otherwise mandated by local laws or regulations.
• Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication

Locations

US (47)