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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
Non-Influenza Comparator (Boostrix)
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Males and females ≥ 65 years old who are healthy or have co-morbidities
  2. 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.
  3. Ability to attend all scheduled visits and to comply with study procedures

Exclusion Criteria:

  1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study
  2. Abnormal function of the immune system.
  3. 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.
  4. Additional eligibility criteria may be discussed by contacting the site

Sites / Locations

  • MHAT St. Ekaterina
  • MHAT Sv Nikolay Chudotvoretz Lom
  • MBAL TRIMONCIUM (Synexus)
  • SHATPPD-Ruse
  • Mhat Silistra
  • Mc Smolyan
  • Mc Avicena Sofia
  • Medical Center Excelsior
  • Medical center Synexus Sofia EOOD
  • SHATPPD-Sofia, City
  • Medical Centre Orpheus OOD (Synexus)
  • Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
  • Caja de Compesanción Familiar CAFAM
  • Fundacion Cardiomet CEQUIN - Internal Medicine
  • Clinica de la Costa
  • Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
  • Medplus Medicina Prepagada
  • Asociacion IPS Medicos Internistas de Caldas
  • CCBR Czech Brno, s.r.o.
  • FN Hradec Kralove
  • Centrum ockovani a cestovni mediciny
  • CCBR Ostrava, s.r.o.
  • CCBR Czech, a.s.
  • Center for Clinical and Basic Research
  • Medicum AS
  • Merelahe Family Doctors Centre
  • Vee Family Doctors Centre
  • Clinical Research Center
  • Family Doctors Pullerits & Gavronski
  • Practice Dr Liga Kozlovska
  • Practice Dr Ruta Eglite
  • Family Doctor Andra Lasmane clinic "ALMA"
  • Practice Dr Inese Petrova
  • JSC Saules seimos medicinos centras
  • Kauno klinikine ligonine
  • Lietuvos Sveikatos Mokslų Universitetas
  • UAB InMedica
  • Klaipeda University Hospital
  • Republican Siauliai Hospital
  • CCBR
  • Hospital Sultanah Bahiyah
  • Hospital Selayang
  • Klinik Kesihatan Greentown
  • Hospital Raja Perempuan Zainab II
  • University Malaya Medical Centre (UMMC)
  • Klinik Kesihatan Seremban 2
  • Hospital Seri Manjung
  • Hospital Sibu
  • De La Salle Health Sciences Institute
  • West Visayas State University - Medical Center
  • Quirino Memorial Medical Center
  • Marilao St. Michael Family Hospital
  • Philippine General Hospital
  • San Juan De Dios Hospital
  • Synexus Polska Sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
  • NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
  • Centrum Medyczne Pratia Warszawa
  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
  • Synexus Polska Sp. z o.o.
  • Centrum Medyczne Pratia Gdynia
  • Centrum Medyczne Pratia Katowice
  • Praktyka Lekarzy Rodzinnych SALUS
  • Synexus Polska Sp. z o.o
  • Centrum Medyczne PRATIA Bydgoszcz
  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
  • RCMed Oddział Nowy Duninow
  • RCMed Oddzial Sochaczew
  • Medical Trials Institute
  • Cabinet dr. Dana OLAR
  • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
  • Cabinet Medical Individual Craciun-Nicodin Maria Marcela
  • Centrul Medical Sana
  • Clinica Medicala Synexus
  • Spitalul Clinic C.F. Cluj-Napoca
  • Clintrial Medical Center
  • Fundatia Cardioprevent
  • Ramathibodi Hospital
  • Mahidol University (MU) - Faculty of Tropical Medicine
  • Khon Kaen University - Srinagarind Hospital - Medicine
  • Bamrasnaradura Infectious Diseases Institute (BIDI)
  • Ankara Training and Research Hospital
  • Hacettepe University Medical Faculty
  • Akdeniz University Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Ataturk University Medical Faculty
  • Ege University Medical Faculty
  • Kocaeli University Research and Application Hospital
  • Sakarya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aQIV

Non-influenza Comparator Vaccine

Arm Description

MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)

Non-influenza comparator vaccine

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
October 15, 2015
Last Updated
June 8, 2020
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT02587221
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
6790 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aQIV
Arm Type
Experimental
Arm Description
MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)
Arm Title
Non-influenza Comparator Vaccine
Arm Type
Placebo Comparator
Arm Description
Non-influenza comparator vaccine
Intervention Type
Biological
Intervention Name(s)
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
Intervention Description
1 dose approximately 0.5 mL of aQIV
Intervention Type
Biological
Intervention Name(s)
Non-Influenza Comparator (Boostrix)
Intervention Description
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
Description
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Time Frame
Day 1 through Day 7
Title
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
Description
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.
Time Frame
Within 30 days after of first occurrence RT-PCR confirmed Influenza
Title
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
Description
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Time Frame
Day 1 through Day 366
Title
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)
Description
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.
Time Frame
Day 1 to Day 366
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
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.
Description
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.
Time Frame
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Title
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
Description
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.
Time Frame
Days 1 and 22
Title
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
Description
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1).
Time Frame
Day 22/Day 1
Title
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
Description
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.
Time Frame
Day 22
Title
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
Description
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.
Time Frame
Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Program Manager
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
MHAT St. Ekaterina
City
Dimitrovgrad
Country
Bulgaria
Facility Name
MHAT Sv Nikolay Chudotvoretz Lom
City
Lom
Country
Bulgaria
Facility Name
MBAL TRIMONCIUM (Synexus)
City
Plovdiv
Country
Bulgaria
Facility Name
SHATPPD-Ruse
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Mhat Silistra
City
Silistra
Country
Bulgaria
Facility Name
Mc Smolyan
City
Smolyan
Country
Bulgaria
Facility Name
Mc Avicena Sofia
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Excelsior
City
Sofia
Country
Bulgaria
Facility Name
Medical center Synexus Sofia EOOD
City
Sofia
Country
Bulgaria
Facility Name
SHATPPD-Sofia, City
City
Sofia
Country
Bulgaria
Facility Name
Medical Centre Orpheus OOD (Synexus)
City
Stara Zagora
Country
Bulgaria
Facility Name
Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
0500515
Country
Colombia
Facility Name
Caja de Compesanción Familiar CAFAM
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
74136-3367
Country
Colombia
Facility Name
Fundacion Cardiomet CEQUIN - Internal Medicine
City
Armenia
ZIP/Postal Code
NAP
Country
Colombia
Facility Name
Clinica de la Costa
City
Barranquilla
ZIP/Postal Code
NAP
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
City
Bogotá
ZIP/Postal Code
NAP
Country
Colombia
Facility Name
Medplus Medicina Prepagada
City
Bogotá
ZIP/Postal Code
NAP
Country
Colombia
Facility Name
Asociacion IPS Medicos Internistas de Caldas
City
Manizales
ZIP/Postal Code
170004
Country
Colombia
Facility Name
CCBR Czech Brno, s.r.o.
City
Brno
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
Country
Czechia
Facility Name
Centrum ockovani a cestovni mediciny
City
Hradec Králové
Country
Czechia
Facility Name
CCBR Ostrava, s.r.o.
City
Ostrava
Country
Czechia
Facility Name
CCBR Czech, a.s.
City
Pardubice
Country
Czechia
Facility Name
Center for Clinical and Basic Research
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
Medicum AS
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
Merelahe Family Doctors Centre
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
Vee Family Doctors Centre
City
Paide
State/Province
Järvamaa
Country
Estonia
Facility Name
Clinical Research Center
City
Tartu
State/Province
Tartumaa
Country
Estonia
Facility Name
Family Doctors Pullerits & Gavronski
City
Tartu
State/Province
Tartumaa
Country
Estonia
Facility Name
Practice Dr Liga Kozlovska
City
Balvi
Country
Latvia
Facility Name
Practice Dr Ruta Eglite
City
Kuldiga
Country
Latvia
Facility Name
Family Doctor Andra Lasmane clinic "ALMA"
City
Riga
Country
Latvia
Facility Name
Practice Dr Inese Petrova
City
Tukums
Country
Latvia
Facility Name
JSC Saules seimos medicinos centras
City
Kaunas
Country
Lithuania
Facility Name
Kauno klinikine ligonine
City
Kaunas
Country
Lithuania
Facility Name
Lietuvos Sveikatos Mokslų Universitetas
City
Kaunas
Country
Lithuania
Facility Name
UAB InMedica
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
Country
Lithuania
Facility Name
Republican Siauliai Hospital
City
Siauliai
Country
Lithuania
Facility Name
CCBR
City
Vilnius
Country
Lithuania
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
Country
Malaysia
Facility Name
Hospital Selayang
City
Batu Caves
Country
Malaysia
Facility Name
Klinik Kesihatan Greentown
City
Ipoh
Country
Malaysia
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
Country
Malaysia
Facility Name
University Malaya Medical Centre (UMMC)
City
Kuala Lumpur
Country
Malaysia
Facility Name
Klinik Kesihatan Seremban 2
City
Seremban
Country
Malaysia
Facility Name
Hospital Seri Manjung
City
Seri Manjung
Country
Malaysia
Facility Name
Hospital Sibu
City
Sibu
Country
Malaysia
Facility Name
De La Salle Health Sciences Institute
City
Dasmariñas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
West Visayas State University - Medical Center
City
Jaro
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Quirino Memorial Medical Center
City
Quezon
State/Province
National Capital Region
ZIP/Postal Code
1109
Country
Philippines
Facility Name
Marilao St. Michael Family Hospital
City
Bulacan
ZIP/Postal Code
3019
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
San Juan De Dios Hospital
City
Pasay
ZIP/Postal Code
1300
Country
Philippines
Facility Name
Synexus Polska Sp. z o.o.
City
Wroclaw
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
City
Plock
State/Province
Mazowieckie
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia
City
Gdynia
State/Province
Pomorskie
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
State/Province
Slaskie
Country
Poland
Facility Name
Praktyka Lekarzy Rodzinnych SALUS
City
Katowice
State/Province
Slaskie
Country
Poland
Facility Name
Synexus Polska Sp. z o.o
City
Poznan
State/Province
Wielkopolskie
Country
Poland
Facility Name
Centrum Medyczne PRATIA Bydgoszcz
City
Bydgoszcz
Country
Poland
Facility Name
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
City
Lodz
Country
Poland
Facility Name
RCMed Oddział Nowy Duninow
City
Nowy Duninow
Country
Poland
Facility Name
RCMed Oddzial Sochaczew
City
Sochaczew
Country
Poland
Facility Name
Medical Trials Institute
City
Torun
Country
Poland
Facility Name
Cabinet dr. Dana OLAR
City
Arad
Country
Romania
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
City
Brasov
Country
Romania
Facility Name
Cabinet Medical Individual Craciun-Nicodin Maria Marcela
City
Bucuresti
Country
Romania
Facility Name
Centrul Medical Sana
City
Bucuresti
Country
Romania
Facility Name
Clinica Medicala Synexus
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic C.F. Cluj-Napoca
City
Cluj
Country
Romania
Facility Name
Clintrial Medical Center
City
Resca
Country
Romania
Facility Name
Fundatia Cardioprevent
City
Timisoara
Country
Romania
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Mahidol University (MU) - Faculty of Tropical Medicine
City
Bangkok
Country
Thailand
Facility Name
Khon Kaen University - Srinagarind Hospital - Medicine
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Diseases Institute (BIDI)
City
Mueang Nonthaburi
Country
Thailand
Facility Name
Ankara Training and Research Hospital
City
Ankara
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Cerrahpaşa
Country
Turkey
Facility Name
Ataturk University Medical Faculty
City
Erzurum
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
Country
Turkey
Facility Name
Kocaeli University Research and Application Hospital
City
Kocaeli
Country
Turkey
Facility Name
Sakarya Training and Research Hospital
City
Sakarya
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33577767
Citation
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.
Results Reference
derived

Learn more about this trial

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

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