A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

Influenza, Human Clinical Trial

Official title:

A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Compared to a Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06087640
• Other study ID #: V118_24
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 23, 2023
• Est. completion date: December 2026

Study information

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

Clinical Trial Summary

This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35800
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

1. Adults of =65 years of age on the day of vaccination.

2. 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.

3. Individuals who have the ability to comply with study procedures including follow-up. Exclusion Criteria: In order to participate in this study, all subjects must not meet any of the exclusion

criteria described below:

1. Bedridden subjects (i.e. confined to bed by sickness or old age).

2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.

3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.

4. 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.

5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.

6. Clinical conditions representing a contra-indication 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 =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;

3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.

9. 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.

10. Acute (severe) febrile illness.

11. 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.

12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

13. Participation in the current study for more than one season.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• aQIV
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1. A 0.5 mL dose of aQIV contains nominally 15 µg of hemagglutinin (HA) of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 µg HA). The strain composition is that recommended by the World Health Organization (WHO) for quadrivalent influenza vaccines contemporaneous to the timing of the study.
• QIV
Participants receive a 0.5-mL intramuscular dose of the non-adjuvanted QIV on Day 1. A 0.5 mL dose of QIV contains nominally 15 µg of HA of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 µg HA). The strain composition is that recommended by the WHO for quadrivalent influenza vaccines contemporaneous to the timing of the study.

Locations

Country	Name	City	State
Belgium	05602-Universitair Ziekenhuis Gent	Gent
Belgium	05603-ResearchLink	Linkebeek
Bulgaria	10005-MHAT Dr. Tota Venkova	Gabrovo
Bulgaria	10018-Medical Center - Zdrave-1	Kozloduy
Bulgaria	10029-Medical Centre Leo Clinic EOOD	Lovech
Bulgaria	10007-Medical Center Hera EOOD	Montana
Bulgaria	10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD	Montana
Bulgaria	10019-MC Med Consult Pleven	Pleven
Bulgaria	10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov	Plovdiv
Bulgaria	10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv	Plovdiv
Bulgaria	10004-Medical Center Prolet EOOD	Ruse
Bulgaria	10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD	Ruse
Bulgaria	10016-Diagnostic Consultative Center - 1 - Sevlievo EOOD	Sevlievo
Bulgaria	10023-DCC-1 Sliven	Sliven
Bulgaria	10006-DCC 22 - Sofia	Sofia
Bulgaria	10015-Medical Center Hera - Pulmonology Office	Sofia
Bulgaria	10021-Medical Center Intermedica	Sofia
Bulgaria	10028-Medical Center Excelsior OOD	Sofia
Bulgaria	10027-AIPPMP D-r Zhaneta Demireva	Stamboliyski
Czechia	20307-CCR Brno s.r.o.	Brno
Czechia	20305-Prof. MUDr. Jiri Beran, s.r.o.	Ceské Budejovice
Czechia	20306-ADMED, s.r.o.	Ceské Budejovice
Czechia	20310-MUDr. Jakub Strincl, s.r.o.	Liberec
Czechia	20309-CCR Ostrava, s.r.o.	Ostrava
Czechia	20308-Zdravi - fit, s.r.o.	Protivín
Finland	24602-Oulu Vaccine Research Clinic	Oulu
Finland	24601-Tampere Vaccine Research Clinic	Tampere
Finland	24604-Turku Vaccine Research Clinic	Turku
Georgia	26803-JSC Evex Hospitals	Batumi
Georgia	26801-LTD Hospital Service	Kutaisi
Georgia	26802-Acad. G. Chapidze Emergency Cardiology Center	Tbilisi
Georgia	26804-K. Eristavi National Center of Clinical Surgery	Tbilisi
Italy	38003-University Hospital Consorziale Policlinico	Bari
Italy	38001-PO A. Manzoni di Lecco, ASST Lecco	Lecco
Italy	38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco	Milano
Korea, Republic of	41002-Korea University Ansan Hospital	Ansan
Korea, Republic of	41001-Inha University Hospital	Incheon
Korea, Republic of	41004-Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	41003-Ajou University Hospital	Suwon
Lithuania	44004-UAB InMedica	Kaunas
Lithuania	44008-JSC Saules Šeimos Medicinos Centras	Kaunas
Lithuania	44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	44010-InlitaJSC Santara CTC	Vilnius
Netherlands	52802-Emotional Brain BV	Almere
Poland	61618-FutureMeds Lodz	Lódz
Poland	61605-RCMed Oddzial Sochaczew	Sochaczew
Poland	61614-KO-MED Centra Kliniczne Staszow	Staszów
Poland	61615-ETG Warszawa	Warsaw
Poland	61616-FutureMeds Targowek	Warsaw
Poland	61617-FutureMeds Sp. z o.o.	Wroclaw
Romania	64210-Sana Monitoring	Bucuresti
Romania	64204-Ames Research Center	Calarasi
Romania	64209-Clintrial Medical Center	Re?ca
Romania	64211-Nova-Clin Medical Research Center	Timisoara
Spain	72402-EAP Vic - CAP El Remei	Barcelona
Spain	72404-Hospital Universitario Son Espases	Palma de Mallorca
Spain	72401-Hospital Povisa	Vigo
Taiwan	15803-Taipei Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	15801-China Medical University Hospital	Taichung
Taiwan	15802-National Cheng Kung University Hospital	Tainan
Taiwan	15804-Taipei Medical University - Wanfang Hospital	Taipei
Taiwan	15805-Taipei Medical University - Taipei Medical University Hospital	Taipei
Turkey	79209-Hacettepe University Faculty of Medicine	Ankara
Turkey	79207-Akdeniz University Faculty of Medicine	Antalya
Turkey	79212-Dicle Universitesi Tip Fakultesi	Diyarbakir
Turkey	79205-Goztepe Suleyman Yalcin City Hospital	Istanbul
Turkey	79204 - Kocaeli University Faculty of Medicine	Kocaeli
Turkey	79211-Karadeniz Technical University Faculty of Medicine	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Finland,  Georgia,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Romania,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction	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)
Secondary	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)
Secondary	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)
Secondary	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	CDC = Centers for Disease Control and Prevention	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)
Secondary	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	WHO = World Health Organization	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains	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.	Day 1 and Day 22
Secondary	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
Secondary	Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination		Day 1
Secondary	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
Secondary	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
Secondary	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