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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02587221
Other study ID # V118_18
Secondary ID 2015-000728-27
Status Completed
Phase Phase 3
First received
Last updated
Start date September 30, 2016
Est. completion date July 23, 2018

Study information

Verified date June 2020
Source Seqirus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 6790
Est. completion date July 23, 2018
Est. primary completion date July 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
1 dose approximately 0.5 mL of aQIV
Non-Influenza Comparator (Boostrix)
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Seqirus

Countries where clinical trial is conducted

Bulgaria,  Colombia,  Czechia,  Estonia,  Latvia,  Lithuania,  Malaysia,  Philippines,  Poland,  Romania,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Primary 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. Day 1 through Day 7
Primary 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. Within 30 days after of first occurrence RT-PCR confirmed Influenza
Primary 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. Day 1 through Day 366
Primary 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. Day 1 to Day 366
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Secondary 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. Days 1 and 22
Secondary 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). Day 22/Day 1
Secondary 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. Day 22
Secondary 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. Day 22
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