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

Study Overview
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Brief Summary
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This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years to determine the appropriate age population for this vaccine. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

Official Title
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A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging 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

Conditions
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Influenza

Intervention / Treatment
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* Drug: aQII-1
* Drug: aQII-3 Investigational
* Drug: aQII-6 Investigational
* Other: aQII-7 Investigational
* Drug: aQII-9 Investigational
* Drug: aQII-10 Investigational
* Drug: aQII-11 Investigational
* Drug: QII Active Comparator


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 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. EXCLUSION CRITERIA: In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below: 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) (see Appendix 2 - List of Adverse Events of Special Interest). 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 vaccination. 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. Study personnel or immediate family or household member of study personnel. 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. Acute (severe) febrile illness (see Section 4.3, Criteria for Delay of Vaccination). 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A aQII-1 Investigational<br> | Drug: aQII-1<br>* Biological/Vaccine: Investigational aQII-1 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.<br>|
| Experimental: Group B aQII-3 Investigational<br> | Drug: aQII-3 Investigational<br>* Biological/Vaccine: Investigational aQII-3 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.<br>|
| Experimental: Group C aQII-6 Investigational<br> | Drug: aQII-6 Investigational<br>* Biological/Vaccine: Investigational aQII-6 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.<br>|
| Experimental: Group D aQII-7 Investigational<br> | Other: aQII-7 Investigational<br>* Biological/Vaccine: Investigational aQII-7 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.<br>|
| Experimental: Group E aQII-9 Investigational<br> | Drug: aQII-9 Investigational<br>* Biological/Vaccine: Investigational aQII-9 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.<br>|
| Experimental: Group F aQII-10 Investigational<br> | Drug: aQII-10 Investigational<br>* Biological/Vaccine: Investigational aQII-10 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.<br>|
| Experimental: Group G aQII-11 Investigational<br> | Drug: aQII-11 Investigational<br>* Biological/Vaccine: Investigational aQII-11 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.<br>|
| Active Comparator: Group H QII Active Comparator<br> | Drug: QII Active Comparator<br>* Biological/Vaccine: Investigational QII 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure: 1. Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains |  | [28 days post-vaccination] |