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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501561
• Other study ID #: V201_07
• Status: Completed
• Phase: Phase 2
• Start date: August 25, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2024
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

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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.

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Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• Experimental: IIV-A Investigational IIV-A will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational IIV-A Investigational Quadrivalent Influenza vaccine, 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.
• Experimental: aIIV-B Investigational aIIV-B will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-B Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
• Experimental: aIIV-C Investigational aIIV-C will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Investigational aIIV-C Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, 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.
• Active Comparator: Licensed IIV IIV will be administered as a single dose intramuscularly on Day 1
Biological/Vaccine: Licensed IIV Licensed Non-adjuvanted Quadrivalent Influenza vaccine, 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.

Locations

Country	Name	City	State
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Meridian Clinical Research	Bellevue	Nebraska
United States	MedPharmics LLC	Biloxi	Mississippi
United States	Meridian Clinical Research (Binghamton, NY)	Binghamton	New York
United States	CVS pharmacy - Charlottesville	Charlottesville	Virginia
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	The Lynn Institute of The Rockies	Colorado Springs	Colorado
United States	Aventiv Research, Inc. Columbus	Columbus	Ohio
United States	Meridian Clinical Research - Dakota Dunes	Dakota Dunes	South Dakota
United States	Velocity Clinical Research - New Smyrna Beach	Edgewater	Florida
United States	AMR El Dorado	El Dorado	Kansas
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Meridian Clinical Research	Grand Island	Nebraska
United States	Velocity Clinical Research - Greenville	Greenville	South Carolina
United States	Healthcare Research Network	Hazelwood	Missouri
United States	CenExel RCA	Hollywood	Florida
United States	Marvel Clinical Research	Huntington Beach	California
United States	Health Awareness INC	Jupiter	Florida
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	AMR Coastal Clinical Research	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC, Las Vegas	Las Vegas	Nevada
United States	AMR Lexington	Lexington	Kentucky
United States	Meridian Clinical Research, LLC	Lincoln	Nebraska
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Medpharmics, LLC	Metairie	Louisiana
United States	Global Health Research Center	Miami Lakes	Florida
United States	Clinical Research Consulting, LLC	Milford	Connecticut
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	CVS pharmacy - Reston	Reston	Virginia
United States	CVS pharmacy - Richmond	Richmond	Virginia
United States	Rockville Internal Medicine Group	Rockville	Maryland
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	JBR Clinical Research	Salt Lake City	Utah
United States	California Research Center	San Diego	California
United States	Meridian Clinical Research - Savannah	Savannah	Georgia
United States	Platinum Research Network, LLC	Savannah	Georgia
United States	Velocity Clinical Research, Spartanburg	Spartanburg	South Carolina
United States	Precision Clinical Research	Sunrise	Florida
United States	Velocity Clinical Research - Syracuse	Syracuse	New York
United States	Global Health Research Center	Tampa	Florida
United States	AMR Tempe	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Velocity Clinical Research - West Jordan	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains		28 days post-vaccination
Primary	The Percentage of Subjects with Solicited Local and Systemic Reactions		7 days post-vaccination
Primary	The Percentage of Subjects with Unsolicited Adverse Events		28 days post-vaccination
Primary	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
Secondary	Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains		28 days post-vaccination