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

Seqirus471 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

471

Conditions

Influenza Human

Interventions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

4022 - Coastal Clinical Research, an AMR company

Mobile, Alabama, United States

4002 - Clinical Research Consortium, an AMR company

Tempe, Arizona, United States

4006 - Westside Center for Clinical Research

Jacksonville, Florida, United States

4013 - Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

4021 - Research Centers of America, LLC

Oakland, Florida, United States

4023 - Advanced Clinical Research

Boise, Idaho, United States

4010 - Heartland Research Associates, LLC

Newton, Kansas, United States

4016 - Heartland Research Associates, LLC - An AMR Company

Wichita, Kansas, United States

4001 - Central Kentucky Research Associates, an AMR company

Lexington, Kentucky, United States

4014 - Medpharmi

Kenner, Louisiana, United States

...and 11 more locations

Outcomes

Primary Outcomes

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

Time frame: 28 days post-vaccination

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

Time frame: 28 days post-vaccination

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

Time frame: 28 days post-vaccination

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

Time frame: 28 days post-vaccination

Secondary Outcomes

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.

Time frame: 7 days post-vaccination

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.

Time frame: 28 days post-vaccination

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

Time frame: 180 days post-vaccination

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

Time frame: 28 days post-vaccination

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

Time frame: 28 days post-vaccination

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

Time frame: 28 days post-vaccination

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

Time frame: 180 days post-vaccination

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

Time frame: 180 days post-vaccination

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

Time frame: 180 days post-vaccination

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

Time frame: 180 days post-vaccination

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

Time frame: 180 days post-vaccination