A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
- Conditions
- Influenza, Human
- Interventions
- Biological: QIV or TIVBiological: aQIV or aTIV
- Registration Number
- NCT06087640
- Lead Sponsor
- Seqirus
- Brief Summary
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35800
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Adults of ≥65 years of age on the day of vaccination.
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who have the ability to comply with study procedures including follow-up.
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
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Bedridden subjects (i.e. confined to bed by sickness or old age).
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Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
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Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
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Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
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Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
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Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
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Abnormal function of the immune system resulting from:
- Clinical conditions;
- Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) 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 are also permitted;
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
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Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
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Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
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Acute (severe) febrile illness.
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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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Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-adjuvanted influenza vaccine QIV or TIV Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain MF59-adjuvanted influenza vaccine aQIV or aTIV MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain
- Primary Outcome Measures
Name Time Method Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season) ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction
- Secondary Outcome Measures
Name Time Method Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) Immunogenicity Endpoint: GMT ratios (adjuvanted/non-adjuvanted) at Day 1 and Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains Day 1 and Day 22 Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains Day 1 and Day 22 Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination Day 1 Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) CDC = Centers for Disease Control and Prevention
Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains Day 1 and Day 22 Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) WHO = World Health Organization
Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season) Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains Day 1 and Day 22 Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains Day 1 and Day 22 Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period Day 1 to Day 181 or the end of the influenza season, whichever is longer Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period Day 1 to Day 181 or the end of the influenza season, whichever is longer Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period Day 1 to Day 181 or the end of the influenza season, whichever is longer
Trial Locations
- Locations (137)
03603-University of the Sunshine Coast
🇦🇺Birtinya, Australia
03609-Paratus Clinical Western Sydney
🇦🇺Blacktown, Australia
03605-Emeritus Research - Sydney
🇦🇺Botany, Australia
03614-Northern Beaches Clinical Research
🇦🇺Brookvale, Australia
03602-Emeritus Research - Melbourne
🇦🇺Camberwell, Australia
03615-Momentum Clinical Research Darlinghurst
🇦🇺Darlinghurst, Australia
03608-Paratus Clinical Brisbane
🇦🇺Herston, Australia
03610-Paratus Clinical Central Coast
🇦🇺Kanwal, Australia
03604-Doherty Clinical Trials Limited
🇦🇺Melbourne, Australia
03611-Nucleus Network
🇦🇺Melbourne, Australia
Scroll for more (127 remaining)03603-University of the Sunshine Coast🇦🇺Birtinya, AustraliaPeter de WetContact