A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

Phase 3

Completed

Conditions: Influenza, Human

Interventions: Biological: Comparator QIV
Biological: aQIV

Registration Number: NCT05044195

Lead Sponsor: Seqirus

Brief Summary: This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2044

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:

Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) 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 study entry and who do not plan to do so until 2 months after the study vaccination
Progressive, unstable or uncontrolled clinical conditions
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
History of any medical condition considered an AESI
Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function of the immune system resulting from:
1. Clinical conditions
2. Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent
Received immunoglobulins or any blood products within 180 days prior to informed consent
Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to)
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period
Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination
Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination
Acute (severe) febrile illness
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
Study personnel or immediate family members or household member of study personnel

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator QIV	Comparator QIV	Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains
aQIV	aQIV	Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains

Primary Outcome Measures

Name	Time	Method
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 22	The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 1 to Day 22	The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 22	The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 1 to Day 181	GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 181	The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 1 to Day 181	Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 1 to Day 181	The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains	Day 1 to Day 181	The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination	Day 1 through Day 7	Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination	Day 1 through Day 22	The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)	Day 1 through Day 271	The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period

Trial Locations

Locations (29): 27608 Klinische Forschung Dresden GmbH
🇩🇪
Dresden, Germany
84006 Alliance for Multispecialty Research
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Kansas City, Missouri, United States
84004 Meridian Clinical Research
🇺🇸
Omaha, Nebraska, United States
27601 Klinische Forschung Hamburg GmbH
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Hamburg, Germany
23302 Vee Family Doctors Centre
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Paide, Estonia
84011 Meridian Clinical Research
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Endwell, New York, United States
27607 Siteworks GmbH
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Hannover, Germany
23304 Merelahe Family Doctors Centre
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Tallinn, Estonia
84005 JEM Research Institute
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Atlantis, Florida, United States
27611 Siteworks GmbH
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Fulda, Germany
23301 Innomedica OÜ - Outpatient
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Tallinn, Estonia
23306 Center for Clinical and Basic Research
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Tallinn, Estonia
27609 IKF Pneumologie GmbH & Co. KG
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Frankfurt, Germany
27603 Emovis GmbH
🇩🇪
Berlin, Germany
84008 United Medical Associates
🇺🇸
Binghamton, New York, United States
23305 Clinical Research Center - Vaccine Trials
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Tartu, Estonia
27604 Klinische Forschung Hannover-Mitte GmbH
🇩🇪
Hannover, Germany
84013 Coastal Clinical Research, Inc.
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Mobile, Alabama, United States
84007 Alliance for Multispecialty Research
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Tempe, Arizona, United States
84009 Meridian Clinical Research
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Lincoln, Nebraska, United States
84001 Meridian Clinical Research
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Savannah, Georgia, United States
84010 Headlands Research Orlando
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Orlando, Florida, United States
84003 Meridian Clinical Research
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Sioux City, Iowa, United States
84002 Meridian Clinical Research
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Norfolk, Nebraska, United States
27606 SIBAmed GmbH & Co KG
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Leipzig, Germany
23303 Al Mare Perearstikeskus OÜ
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Tallinn, Estonia
27610 Studienzentrum Leitz Triderm
🇩🇪
Stuttgart, Germany
27605 Clinical Research Hamburg GmbH
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Hamburg, Germany
27602 Klinische Forschung Berlin
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Berlin, Germany