Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06087640




Registration number
NCT06087640
Ethics application status
Date submitted
28/09/2023
Date registered
18/10/2023
Date last updated
10/07/2025

Titles & IDs
Public title
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
Scientific title
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Subunit Inactivated Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults =65 Years of Age
Secondary ID [1] 0 0
V118_24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - aQIV or aTIV
Treatment: Other - QIV or TIV

Experimental: MF59-adjuvanted influenza vaccine - 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

Other: Non-adjuvanted influenza vaccine - 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


Treatment: Other: aQIV or aTIV
Participants receive a 0.5-mL intramuscular dose of aQIV or aTIV 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). A 0.5 mL dose of aTIV contains nominally 15 µg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 µg HA). The strain composition of aQIV and aTIV is that recommended by the World Health Organization (WHO) for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.

Treatment: Other: QIV or TIV
Participants receive a 0.5-mL intramuscular dose of the non-adjuvanted QIV or TIV 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). A 0.5 mL dose of TIV contains nominally 15 µg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 µg HA). The strain composition of QIV and TIV is that recommended by the WHO for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
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 outcome [1] 0 0
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
Timepoint [1] 0 0
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 outcome [2] 0 0
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
Timepoint [2] 0 0
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 outcome [3] 0 0
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
Timepoint [3] 0 0
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 outcome [4] 0 0
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
Timepoint [4] 0 0
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 outcome [5] 0 0
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
Timepoint [5] 0 0
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 outcome [6] 0 0
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
Timepoint [6] 0 0
Day 1 and Day 22
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Day 1 and Day 22
Secondary outcome [8] 0 0
Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Timepoint [8] 0 0
Day 1 and Day 22
Secondary outcome [9] 0 0
Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Timepoint [9] 0 0
Day 1 and Day 22
Secondary outcome [10] 0 0
Immunogenicity Endpoint: Percentage of subjects with HI titer =1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Timepoint [10] 0 0
Day 1 and Day 22
Secondary outcome [11] 0 0
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination
Timepoint [11] 0 0
Day 1
Secondary outcome [12] 0 0
Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period
Timepoint [12] 0 0
Day 1 to Day 181 or the end of the influenza season, whichever is longer
Secondary outcome [13] 0 0
Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period
Timepoint [13] 0 0
Day 1 to Day 181 or the end of the influenza season, whichever is longer
Secondary outcome [14] 0 0
Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period
Timepoint [14] 0 0
Day 1 to Day 181 or the end of the influenza season, whichever is longer

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
35800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
03603-University of the Sunshine Coast - Birtinya
Recruitment hospital [2] 0 0
03609-Paratus Clinical Western Sydney - Blacktown
Recruitment hospital [3] 0 0
03605-Emeritus Research - Sydney - Botany
Recruitment hospital [4] 0 0
03614-Northern Beaches Clinical Research - Brookvale
Recruitment hospital [5] 0 0
03602-Emeritus Research - Melbourne - Camberwell
Recruitment hospital [6] 0 0
03615-Momentum Clinical Research Darlinghurst - Darlinghurst
Recruitment hospital [7] 0 0
03608-Paratus Clinical Brisbane - Herston
Recruitment hospital [8] 0 0
03610-Paratus Clinical Central Coast - Kanwal
Recruitment hospital [9] 0 0
03604-Doherty Clinical Trials Limited - Melbourne
Recruitment hospital [10] 0 0
03611-Nucleus Network - Melbourne
Recruitment hospital [11] 0 0
03601-University of the Sunshine Coast - Morayfield - Morayfield
Recruitment hospital [12] 0 0
03607-University of the Sunshine Coast - South Bank - South Brisbane
Recruitment hospital [13] 0 0
03613-Momentum Clinical Research Taringa - Taringa
Recruitment hospital [14] 0 0
03612-Wollongong Clinical Reserach - Wollongong
Recruitment postcode(s) [1] 0 0
- Birtinya
Recruitment postcode(s) [2] 0 0
- Blacktown
Recruitment postcode(s) [3] 0 0
- Botany
Recruitment postcode(s) [4] 0 0
- Brookvale
Recruitment postcode(s) [5] 0 0
- Camberwell
Recruitment postcode(s) [6] 0 0
- Darlinghurst
Recruitment postcode(s) [7] 0 0
- Herston
Recruitment postcode(s) [8] 0 0
- Kanwal
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Morayfield
Recruitment postcode(s) [11] 0 0
- South Brisbane
Recruitment postcode(s) [12] 0 0
- Taringa
Recruitment postcode(s) [13] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Gozée
Country [4] 0 0
Belgium
State/province [4] 0 0
Ypres
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Gabrovo
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Kozloduy
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Lovech
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Montana
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Pazardzhik
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Pleven
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Ruse
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sevlievo
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sliven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Stamboliyski
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Liberec
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czechia
State/province [20] 0 0
Protivin
Country [21] 0 0
Czechia
State/province [21] 0 0
Preštice
Country [22] 0 0
Czechia
State/province [22] 0 0
Ceské Budejovice
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Oulu
Country [25] 0 0
Finland
State/province [25] 0 0
Tampere
Country [26] 0 0
Finland
State/province [26] 0 0
Turku
Country [27] 0 0
Georgia
State/province [27] 0 0
Batumi
Country [28] 0 0
Georgia
State/province [28] 0 0
Kutaisi
Country [29] 0 0
Georgia
State/province [29] 0 0
Tbilisi
Country [30] 0 0
Italy
State/province [30] 0 0
Bari
Country [31] 0 0
Italy
State/province [31] 0 0
Lecco
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Ansan
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Incheon
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Suwon
Country [37] 0 0
Lithuania
State/province [37] 0 0
Kaunas
Country [38] 0 0
Lithuania
State/province [38] 0 0
Vilnius
Country [39] 0 0
Netherlands
State/province [39] 0 0
Almere
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
New Zealand
State/province [41] 0 0
Grafton
Country [42] 0 0
New Zealand
State/province [42] 0 0
Mount Cook
Country [43] 0 0
New Zealand
State/province [43] 0 0
New Lynn
Country [44] 0 0
New Zealand
State/province [44] 0 0
Takapuna
Country [45] 0 0
Philippines
State/province [45] 0 0
Bacoor
Country [46] 0 0
Philippines
State/province [46] 0 0
Cebu
Country [47] 0 0
Philippines
State/province [47] 0 0
Dasmariñas
Country [48] 0 0
Philippines
State/province [48] 0 0
Davao City
Country [49] 0 0
Philippines
State/province [49] 0 0
Iloilo City
Country [50] 0 0
Philippines
State/province [50] 0 0
Manila
Country [51] 0 0
Philippines
State/province [51] 0 0
Marilao
Country [52] 0 0
Philippines
State/province [52] 0 0
Pasay
Country [53] 0 0
Philippines
State/province [53] 0 0
Quezon City
Country [54] 0 0
Philippines
State/province [54] 0 0
Silang
Country [55] 0 0
Poland
State/province [55] 0 0
Kraków
Country [56] 0 0
Poland
State/province [56] 0 0
Lublin
Country [57] 0 0
Poland
State/province [57] 0 0
Pulawy
Country [58] 0 0
Poland
State/province [58] 0 0
Staszów
Country [59] 0 0
Poland
State/province [59] 0 0
Warsaw
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Poland
State/province [62] 0 0
Zamosc
Country [63] 0 0
Poland
State/province [63] 0 0
Lódz
Country [64] 0 0
Romania
State/province [64] 0 0
Bucuresti
Country [65] 0 0
Romania
State/province [65] 0 0
Caracal
Country [66] 0 0
Romania
State/province [66] 0 0
Calarasi
Country [67] 0 0
Romania
State/province [67] 0 0
Re?ca
Country [68] 0 0
Romania
State/province [68] 0 0
Timisoara
Country [69] 0 0
South Africa
State/province [69] 0 0
Bloemfontein
Country [70] 0 0
South Africa
State/province [70] 0 0
Brits
Country [71] 0 0
South Africa
State/province [71] 0 0
Cape Town
Country [72] 0 0
South Africa
State/province [72] 0 0
Krugersdorp
Country [73] 0 0
South Africa
State/province [73] 0 0
Middelburg
Country [74] 0 0
South Africa
State/province [74] 0 0
Newtown
Country [75] 0 0
South Africa
State/province [75] 0 0
Paarl
Country [76] 0 0
South Africa
State/province [76] 0 0
Pretoria
Country [77] 0 0
South Africa
State/province [77] 0 0
Thabazimbi
Country [78] 0 0
South Africa
State/province [78] 0 0
Vereeniging
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Cadiz
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Palma de Mallorca
Country [83] 0 0
Spain
State/province [83] 0 0
Santiago De Compostela
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
Vigo
Country [86] 0 0
Taiwan
State/province [86] 0 0
New Taipei City
Country [87] 0 0
Taiwan
State/province [87] 0 0
Taichung
Country [88] 0 0
Taiwan
State/province [88] 0 0
Tainan
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei
Country [90] 0 0
Turkey
State/province [90] 0 0
Ankara
Country [91] 0 0
Turkey
State/province [91] 0 0
Antalya
Country [92] 0 0
Turkey
State/province [92] 0 0
Diyarbakir
Country [93] 0 0
Turkey
State/province [93] 0 0
Istanbul
Country [94] 0 0
Turkey
State/province [94] 0 0
Izmir
Country [95] 0 0
Turkey
State/province [95] 0 0
Kocaeli
Country [96] 0 0
Turkey
State/province [96] 0 0
Trabzon
Country [97] 0 0
Zimbabwe
State/province [97] 0 0
Harare

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Program Director
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Disclosure Manager
Address 0 0
Country 0 0
Phone 0 0
+1 855 358 8966
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06087640