Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576702
• Other study ID #: V200_10
• Status: Completed
• Phase: Phase 2
• Start date: October 8, 2020
• Est. completion date: May 24, 2021

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: May 24, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Individuals 50 years of age and older 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:

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 until 2 months after the study vaccination.

2. Progressive, unstable or uncontrolled clinical conditions.

3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.

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

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. Received immunoglobulins or any blood products within 180 days prior to informed consent.

9. Received an investigational or non-registered medicinal product within 30 days prior to vaccination.

10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.

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

12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.

13. Acute (severe) febrile illness

14. 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.

Related Conditions & MeSH terms

• Human
• Influenza
• Influenza, Human

Intervention

Biological:
• Investigational aIIV4c
Investigational MF59 Adjuvanted Cell-derived 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.
• IIV4c
Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
• aIIV4
Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
• RIV4
Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.

Locations

Country	Name	City	State
United States	4007 - Regional Clinical Research / United Medical Associates	Binghamton	New York
United States	4023 - Advanced Clinical Research	Boise	Idaho
United States	4004 - Sterling research	Cincinnati	Ohio
United States	4017 - Rapid Medical Research, Inc.	Cleveland	Ohio
United States	4006 - Westside Center for Clinical Research	Jacksonville	Florida
United States	4013 - Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	4008 - The Center for Pharmaceutical Research, an AMR company	Kansas City	Missouri
United States	4014 - Medpharmi	Kenner	Louisiana
United States	4001 - Central Kentucky Research Associates, an AMR company	Lexington	Kentucky
United States	4022 - Coastal Clinical Research, an AMR company	Mobile	Alabama
United States	4010 - Heartland Research Associates, LLC	Newton	Kansas
United States	4021 - Research Centers of America, LLC	Oakland	Florida
United States	4011 - Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	4009 - Meridian Clinical Research, LLC	Omaha	Nebraska
United States	4012 - M3 Wake Research, Inc.	Raleigh	North Carolina
United States	4024 - Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	4005 - Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	4002 - Clinical Research Consortium, an AMR company	Tempe	Arizona
United States	4018 - Martin Diagnostic Clinic	Tomball	Texas
United States	4020 - Advanced Clinical Research	West Jordan	Utah
United States	4016 - Heartland Research Associates, LLC - An AMR Company	Wichita	Kansas

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: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses		28 days post-vaccination
Primary	Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses		28 days post-vaccination
Primary	Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses	Seroconversion is defined as =4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (=1:10), or a post-vaccination titer =1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers	28 days post-vaccination
Primary	Immunogenicity Endpoint: Percentage of Subjects With HI Titer =1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses		28 days post-vaccination
Secondary	Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions	The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.	7 days post-vaccination
Secondary	Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events	The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.; Related AEs = considered at least possibly related to study vaccination by the investigator.	28 days post-vaccination
Secondary	Safety Endpoint: 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) During the Entire Study Period		180 days post-vaccination
Secondary	Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses		28 days post-vaccination
Secondary	Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses		28 days post-vaccination
Secondary	Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses	Seroconversion is defined as =4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (=1:10), or a post-vaccination titer =1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers	28 days post-vaccination
Secondary	Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses		180 days post-vaccination
Secondary	Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses		180 days post-vaccination
Secondary	Immunogenicity Endpoint: Percentage of Subjects With HI Titer =1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses		180 days post-vaccination
Secondary	Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses		180 days post-vaccination
Secondary	Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses		180 days post-vaccination