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

NCT02587221 | Completed Phase 3 Results DMC

• 2 other identifiers: V118_182015-000728-27
• Study Type: interventional
• Target: 6,790
• Locations: 12 countries
• Sites: 89

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 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.

  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.

  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.

  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.

  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.

  Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer

Study Arms (2)

aQIV

EXPERIMENTAL

MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)

Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)

Non-influenza Comparator Vaccine

PLACEBO COMPARATOR

Non-influenza comparator vaccine

Biological: Non-Influenza Comparator (Boostrix)

Interventions

MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) BIOLOGICAL

1 dose approximately 0.5 mL of aQIV

aQIV

Non-Influenza Comparator (Boostrix) BIOLOGICAL

1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)

Non-influenza Comparator Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seqirus: lead

Study Sites (89)

MHAT St. Ekaterina

Dimitrovgrad, Bulgaria

Location

MHAT Sv Nikolay Chudotvoretz Lom

Lom, Bulgaria

Location

MBAL TRIMONCIUM (Synexus)

Plovdiv, Bulgaria

Location

SHATPPD-Ruse

Rousse, 7000, Bulgaria

Location

Mhat Silistra

Silistra, Bulgaria

Location

Mc Smolyan

Smolyan, Bulgaria

Location

Mc Avicena Sofia

Sofia, Bulgaria

Location

Medical Center Excelsior

Sofia, Bulgaria

Location

Medical center Synexus Sofia EOOD

Sofia, Bulgaria

Location

SHATPPD-Sofia, City

Sofia, Bulgaria

Location

Medical Centre Orpheus OOD (Synexus)

Stara Zagora, Bulgaria

Location

Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E

Medellín, Antioquia, 0500515, Colombia

Location

Caja de Compesanción Familiar CAFAM

Bogotá, Cundinamarca, 74136-3367, Colombia

Location

Fundacion Cardiomet CEQUIN - Internal Medicine

Armenia, NAP, Colombia

Location

Clinica de la Costa

Barranquilla, NAP, Colombia

Location

Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.

Bogotá, NAP, Colombia

Location

Medplus Medicina Prepagada

Bogotá, NAP, Colombia

Location

Asociacion IPS Medicos Internistas de Caldas

Manizales, 170004, Colombia

Location

CCBR Czech Brno, s.r.o.

Brno, Czechia

Location

Centrum ockovani a cestovni mediciny

Hradec Králové, Czechia

Location

FN Hradec Kralove

Hradec Králové, Czechia

Location

CCBR Ostrava, s.r.o.

Ostrava, Czechia

Location

CCBR Czech, a.s.

Pardubice, Czechia

Location

Center for Clinical and Basic Research

Tallinn, Harju, Estonia

Location

Medicum AS

Tallinn, Harju, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, Harju, Estonia

Location

Vee Family Doctors Centre

Paide, Järvamaa, Estonia

Location

Clinical Research Center

Tartu, Tartu, Estonia

Location

Family Doctors Pullerits & Gavronski

Tartu, Tartu, Estonia

Location

Practice Dr Liga Kozlovska

Balvi, Latvia

Location

Practice Dr Ruta Eglite

Kuldīga, Latvia

Location

Family Doctor Andra Lasmane clinic "ALMA"

Riga, Latvia

Location

Practice Dr Inese Petrova

Tukums, Latvia

Location

JSC Saules seimos medicinos centras

Kaunas, Lithuania

Location

Kauno klinikine ligonine

Kaunas, Lithuania

Location

Lietuvos Sveikatos Mokslų Universitetas

Kaunas, Lithuania

Location

UAB InMedica

Kaunas, Lithuania

Location

Klaipeda University Hospital

Klaipėda, Lithuania

Location

Republican Siauliai Hospital

Šiauliai, Lithuania

Location

CCBR

Vilnius, Lithuania

Location

Hospital Sultanah Bahiyah

Alor Star, Malaysia

Location

Hospital Selayang

Batu Caves, Malaysia

Location

Klinik Kesihatan Greentown

Ipoh, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Malaysia

Location

University Malaya Medical Centre (UMMC)

Kuala Lumpur, Malaysia

Location

Klinik Kesihatan Seremban 2

Seremban, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, Malaysia

Location

Hospital Sibu

Sibu, Malaysia

Location

De La Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

West Visayas State University - Medical Center

Jaro, Iloilo, 5000, Philippines

Location

Quirino Memorial Medical Center

Quezon City, National Capital Region, 1109, Philippines

Location

Marilao St. Michael Family Hospital

Bulacan, 3019, Philippines

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

San Juan De Dios Hospital

Pasay, 1300, Philippines

Location

Synexus Polska Sp. z o.o

Poznan, Greater Poland Voivodeship, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej VITAMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Location

Synexus Polska Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, Poland

Location

NZOZ Centrum Medyczne "OMEGA" sp. z o.o.

Płock, Masovian Voivodeship, Poland

Location

Centrum Medyczne Pratia Warszawa

Warsaw, Masovian Voivodeship, Poland

Location

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego

Warsaw, Masovian Voivodeship, Poland

Location

Synexus Polska Sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

Location

Praktyka Lekarzy Rodzinnych SALUS

Katowice, Silesian Voivodeship, Poland

Location

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz, Poland

Location

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.

Lodz, Poland

Location

RCMed Oddział Nowy Duninow

Nowy Duninów, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, Poland

Location

Medical Trials Institute

Torun, Poland

Location

Cabinet dr. Dana OLAR

Arad, Romania

Location

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

Brasov, Romania

Location

Cabinet Medical Individual Craciun-Nicodin Maria Marcela

Bucharest, Romania

Location

Centrul Medical Sana

Bucharest, Romania

Location

Clinica Medicala Synexus

Bucharest, Romania

Location

Spitalul Clinic C.F. Cluj-Napoca

Cluj-Napoca, Romania

Location

Clintrial Medical Center

Reșca, Romania

Location

Fundatia Cardioprevent

Timișoara, Romania

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Mahidol University (MU) - Faculty of Tropical Medicine

Bangkok, Thailand

Location

Khon Kaen University - Srinagarind Hospital - Medicine

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Diseases Institute (BIDI)

Nonthaburi, Thailand

Location

Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Cerrahpaşa, Turkey (Türkiye)

Location

Ataturk University Medical Faculty

Erzurum, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Location

Kocaeli University Research and Application Hospital

Kocaeli, Turkey (Türkiye)

Location

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33577767 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Seqirus Clinical Trial Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Program Manager

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 27, 2015
• Study Start: September 30, 2016
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: June 17, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-06

Locations

MY (8); CO (7); LI (7); CZ (5); TH (4); TU (8); PH (6); BU (11); RO (8); PL (15); LA (4); ES (6)