InfluenzaPhase 3NCT02587221
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
A Phase 3 study testing MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) and Non-Influenza Comparator (Boostrix) in people with Influenza, run by Seqirus at 89 sites in 12 countries.
Trial summary
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) and Non-Influenza Comparator (Boostrix)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,790 participants
- Where
- 89 sitesin 12 countries
- Study dates
- 30 Sep 2016to 23 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females ≥ 65 years old who are healthy or have co-morbidities
- Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Ability to attend all scheduled visits and to comply with study procedures
Who cannot join
- Hypersensitivity, including allergy to any component of vaccines foreseen in this study
- Abnormal function of the immune system.
- Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
- Additional eligibility criteria may be discussed by contacting the site
Trial locations and contacts
89 sites in 12 countries.
89 sites in 12 countries
Poland15 sites
Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Centrum Medyczne PRATIA Bydgoszcz
Bydgoszcz
Synexus Polska Sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-382
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship
Praktyka Lekarzy Rodzinnych SALUS
Katowice, Silesian Voivodeship
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
Lodz
RCMed Oddział Nowy Duninow
Nowy Duninów
NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
Płock, Masovian Voivodeship
Synexus Polska Sp. z o.o
Poznan, Greater Poland Voivodeship
RCMed Oddzial Sochaczew
Sochaczew
Medical Trials Institute
Torun
Centrum Medyczne Pratia Warszawa
Warsaw, Masovian Voivodeship
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
Warsaw, Masovian Voivodeship
Synexus Polska Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship
Bulgaria11 sites
MHAT St. Ekaterina
Dimitrovgrad
MHAT Sv Nikolay Chudotvoretz Lom
Lom
MBAL TRIMONCIUM (Synexus)
Plovdiv
SHATPPD-Ruse
Rousse, 7000
Mhat Silistra
Silistra
Mc Smolyan
Smolyan
Mc Avicena Sofia
Sofia
Medical Center Excelsior
Sofia
Medical center Synexus Sofia EOOD
Sofia
SHATPPD-Sofia, City
Sofia
Medical Centre Orpheus OOD (Synexus)
Stara Zagora
Malaysia8 sites
Hospital Sultanah Bahiyah
Alor Star
Hospital Selayang
Batu Caves
Klinik Kesihatan Greentown
Ipoh
Hospital Raja Perempuan Zainab II
Kota Bharu
University Malaya Medical Centre (UMMC)
Kuala Lumpur
Klinik Kesihatan Seremban 2
Seremban
Hospital Seri Manjung
Seri Manjung
Hospital Sibu
Sibu
Romania8 sites
Cabinet dr. Dana OLAR
Arad
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
Brasov
Cabinet Medical Individual Craciun-Nicodin Maria Marcela
Bucharest
Centrul Medical Sana
Bucharest
Clinica Medicala Synexus
Bucharest
Spitalul Clinic C.F. Cluj-Napoca
Cluj-Napoca
Clintrial Medical Center
Reșca
Fundatia Cardioprevent
Timișoara
Turkey (Türkiye)8 sites
Ankara Training and Research Hospital
Ankara
Hacettepe University Medical Faculty
Ankara
Akdeniz University Medical Faculty
Antalya
Istanbul University Cerrahpasa Medical Faculty
Cerrahpaşa
Ataturk University Medical Faculty
Erzurum
Ege University Medical Faculty
Izmir
Kocaeli University Research and Application Hospital
Kocaeli
Sakarya Training and Research Hospital
Sakarya
Colombia7 sites
Fundacion Cardiomet CEQUIN - Internal Medicine
Armenia, NAP
Clinica de la Costa
Barranquilla, NAP
Caja de Compesanción Familiar CAFAM
Bogotá, Cundinamarca, 74136-3367
Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
Bogotá, NAP
Medplus Medicina Prepagada
Bogotá, NAP
Asociacion IPS Medicos Internistas de Caldas
Manizales, 170004
Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
Medellín, Antioquia, 0500515
Lithuania7 sites
JSC Saules seimos medicinos centras
Kaunas
Kauno klinikine ligonine
Kaunas
Lietuvos Sveikatos Mokslų Universitetas
Kaunas
UAB InMedica
Kaunas
Klaipeda University Hospital
Klaipėda
Republican Siauliai Hospital
Šiauliai
CCBR
Vilnius
Estonia6 sites
Vee Family Doctors Centre
Paide, Järvamaa
Center for Clinical and Basic Research
Tallinn, Harju
Medicum AS
Tallinn, Harju
Merelahe Family Doctors Centre
Tallinn, Harju
Clinical Research Center
Tartu, Tartu
Family Doctors Pullerits & Gavronski
Tartu, Tartu
Philippines6 sites
Marilao St. Michael Family Hospital
Bulacan, 3019
De La Salle Health Sciences Institute
Dasmariñas, Cavite, 4114
West Visayas State University - Medical Center
Jaro, Iloilo, 5000
Philippine General Hospital
Manila, 1000
San Juan De Dios Hospital
Pasay, 1300
Quirino Memorial Medical Center
Quezon City, National Capital Region, 1109
Czechia5 sites
CCBR Czech Brno, s.r.o.
Brno
Centrum ockovani a cestovni mediciny
Hradec Králové
FN Hradec Kralove
Hradec Králové
CCBR Ostrava, s.r.o.
Ostrava
CCBR Czech, a.s.
Pardubice
Latvia4 sites
Practice Dr Liga Kozlovska
Balvi
Practice Dr Ruta Eglite
Kuldīga
Family Doctor Andra Lasmane clinic "ALMA"
Riga
Practice Dr Inese Petrova
Tukums
Thailand4 sites
Ramathibodi Hospital
Bangkok, 10400
Mahidol University (MU) - Faculty of Tropical Medicine
Bangkok
Khon Kaen University - Srinagarind Hospital - Medicine
Khon Kaen, 40002
Bamrasnaradura Infectious Diseases Institute (BIDI)
Nonthaburi
About this study
Official title: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
- Conditions
- Influenza
- Being tested
- MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV), Non-Influenza Comparator (Boostrix)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)Biological
1 dose approximately 0.5 mL of aQIV
Non-Influenza Comparator (Boostrix)Biological
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
| Study group | Role | What they receive |
|---|---|---|
| aQIV | Experimental | MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV) Receives: Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) |
| Non-influenza Comparator Vaccine | Placebo comparator | Non-influenza comparator vaccine Receives: Biological: Non-Influenza Comparator (Boostrix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.
The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Measured: Day 1 through Day 7
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza.
Measured: Within 30 days after of first occurrence RT-PCR confirmed Influenza
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Measured: Day 1 through Day 366
Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI)
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination.
Measured: Day 1 to Day 366
Secondary outcomes (11)
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary efficacy endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Measured: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
The log-transformed antibody titers (GMT) at Day 1 and Day 22 were evaluated using an analysis of covariance (ANCOVA) model including factors for site/country, pre-vaccination titer, age, and comorbidity.
Measured: Days 1 and 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1).
Measured: Day 22/Day 1
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
The percentage of subjects vaccinated with aQIV with a HI antibody titers ≥1:40 was assessed for each of the 4 strains Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for percent of subjects with HI antibody titer ≥1:40 met or exceeded 60% at Day 22.
Measured: Day 22
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
The percentage of subjects achieving SCR at Day 22 was assessed for each of the 4 strains. SCR is defined as HI titer ≥1:40 for subjects seronegative at baseline (HI titer <1:10) or a minimum 4-fold increase in HI titer for subjects seropositive at baseline (HI titer ≥1:10) on Day 22. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody SCR met or exceeded 30% at Day 22.
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start30 Sep 2016
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6,790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Program Manager, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587221
- Sponsor's protocol ID
- V118_18
- Other IDs
- 2015-000728-27, 2015
- Status last verified
- Jun 2020
- First submitted
- 15 Oct 2015
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Beran J, Reynales H, Poder A, Yu CY, Pitisuttithum P, Yuan LL, Vermeulen W, Verhoeven C, Leav B, Zhang B, Sawlwin D, Hamers-Heijnen E, Edelman J, Smolenov I. Prevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy study. Lancet Infect Dis. 2021 Jul;21(7):1027-1037. doi: 10.1016/S1473-3099(20)30694-0. Epub 2021 Feb 9.
PubMed 33577767
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
- ClinicalTrials.gov ID
- NCT02587221
- Acronym / sponsor ID
- V118_18
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,790 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aQIV | Experimental | Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV) |
| Non-influenza Comparator Vaccine | Placebo comparator | Biological: Non-Influenza Comparator (Boostrix)Non-influenza comparator vaccine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Males and females ≥ 65 years old who are healthy or have co-morbidities
- Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Ability to attend all scheduled visits and to comply with study procedures
Key exclusion criteria (4 listed)
- Hypersensitivity, including allergy to any component of vaccines foreseen in this study
- Abnormal function of the immune system.
- Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
- Additional eligibility criteria may be discussed by contacting the site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)1 dose approximately 0.5 mL of aQIV | Biological | aQIV |
| Non-Influenza Comparator (Boostrix)1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix) | Biological | Non-influenza Comparator Vaccine |
Primary outcome
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint.
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
Time frame: Day 1 through Day 7
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
Time frame: Within 30 days after of first occurrence RT-PCR confirmed Influenza
Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza.
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
Time frame: Day 1 through Day 366
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI)
Time frame: Day 1 to Day 366
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination.
11 secondary outcomes
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition.
Time frame: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
Time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
Time frame: Days 1 and 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
Time frame: Day 22/Day 1
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
Time frame: Day 22
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
Time frame: Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33577767Beran J, Reynales H, Poder A, Yu CY, Pitisuttithum P, Yuan LL, Vermeulen W, Verhoeven C, Leav B, Zhang B, Sawlwin D, Hamers-Heijnen E, Edelman J, Smolenov I. Prevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy study. Lancet Infect Dis. 2021 Jul;21(7):1027-1037. doi: 10.1016/S1473-3099(20)30694-0. Epub 2021 Feb 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Program Manager study director
Seqirus
89 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) and Non-Influenza Comparator (Boostrix) in people with Influenza, run by Seqirus at 89 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Poland, Bulgaria, Malaysia, Romania, Turkey (Türkiye) and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. (time frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.