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A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

Primary Purpose

Influenza, Human

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aQIV
QIV
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Vaccine, MF59 adjuvant, aQIV, A/H1N1, A/H3N2, B/Yamagata, B/Victoria

Eligibility Criteria

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

Inclusion Criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. Adults of ≥65 years of age on the day of vaccination. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who have the ability to comply with study procedures including follow-up. Exclusion Criteria: In order to participate in this study, all subjects must not meet any of the exclusion criteria described below: Bedridden subjects (i.e. confined to bed by sickness or old age). Subjects that are incapacitated and because of that in need of a Legally Authorized Representative. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw. Abnormal function of the immune system resulting from: Clinical conditions; Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period. Acute (severe) febrile illness. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel. Participation in the current study for more than one season.

Sites / Locations

  • 26803 - JSC Evex Hospitals
  • 26801 - LTD Hospital Service
  • 26802 - LTD Emergency Cardiology Center
  • 26804 - JSC Eristavi National Center
  • 79209 - Hacettepe University Faculty of Medicine
  • 79202 - Ankara University Faculty of Medicine
  • 79207 - Akdeniz University Faculty of Medicine
  • 79212 - Dicle University Faculty of Medicine
  • 79201 - Liv Hospital Vadistanbul
  • 79205 - Goztepe Suleyman Yalcin City Hospital
  • 79203 - Acibadem Atakent Hospital
  • 79213 - Ege University Faculty of Medicine
  • 79208 - Izmir Dr. Suat Seren Pulmonary Hospital
  • 79210 - Dokuz Eylul University Faculty of Medicine
  • 79204 - Kocaeli University Faculty of Medicine
  • 79206 - Ondokuz Mayis University Faculty of Medicine
  • 79211 - Karadeniz Technical University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

aQIV

Comparator QIV

Arm Description

MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains

Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains

Outcomes

Primary Outcome Measures

Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction

Secondary Outcome Measures

Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition
CDC = Centers for Disease Control and Prevention
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition
WHO = World Health Organization
Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.
Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination
Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period
Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period
Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period

Full Information

First Posted
September 28, 2023
Last Updated
October 11, 2023
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT06087640
Brief Title
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age
Official Title
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Compared to a Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 3 study is a randomized, observer-blind study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a non-adjuvanted quadrivalent influenza vaccine (QIV) in adults ≥65 years of age. The aim of the study is to evaluate aQIV compared with QIV in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Influenza, Vaccine, MF59 adjuvant, aQIV, A/H1N1, A/H3N2, B/Yamagata, B/Victoria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aQIV
Arm Type
Experimental
Arm Description
MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Arm Title
Comparator QIV
Arm Type
Other
Arm Description
Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains
Intervention Type
Biological
Intervention Name(s)
aQIV
Other Intervention Name(s)
Fluad Tetra/Quadrivalent
Intervention Description
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1. A 0.5 mL dose of aQIV contains nominally 15 µg of hemagglutinin (HA) of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 µg HA). The strain composition is that recommended by the World Health Organization (WHO) for quadrivalent influenza vaccines contemporaneous to the timing of the study.
Intervention Type
Biological
Intervention Name(s)
QIV
Intervention Description
Participants receive a 0.5-mL intramuscular dose of the non-adjuvanted QIV on Day 1. A 0.5 mL dose of QIV contains nominally 15 μg of HA of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 μg HA). The strain composition is that recommended by the WHO for quadrivalent influenza vaccines contemporaneous to the timing of the study.
Primary Outcome Measure Information:
Title
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
Description
ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season)
Secondary Outcome Measure Information:
Title
Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Title
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Title
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition
Description
CDC = Centers for Disease Control and Prevention
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Title
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition
Description
WHO = World Health Organization
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Title
Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition
Time Frame
From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Title
Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Time Frame
Day 1 and Day 22
Title
Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Time Frame
Day 1 and Day 22
Title
Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Description
Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.
Time Frame
Day 1 and Day 22
Title
Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
Time Frame
Day 1 and Day 22
Title
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination
Time Frame
Day 1
Title
Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period
Time Frame
Day 1 to Day 181 or the end of the influenza season, whichever is longer
Title
Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period
Time Frame
Day 1 to Day 181 or the end of the influenza season, whichever is longer
Title
Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period
Time Frame
Day 1 to Day 181 or the end of the influenza season, whichever is longer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. Adults of ≥65 years of age on the day of vaccination. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who have the ability to comply with study procedures including follow-up. Exclusion Criteria: In order to participate in this study, all subjects must not meet any of the exclusion criteria described below: Bedridden subjects (i.e. confined to bed by sickness or old age). Subjects that are incapacitated and because of that in need of a Legally Authorized Representative. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw. Abnormal function of the immune system resulting from: Clinical conditions; Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period. Acute (severe) febrile illness. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel. Participation in the current study for more than one season.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure Manager
Phone
+1 855 358 8966
Email
seqirus.clinicaltrials@seqirus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Use Central Contact
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Program Director
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
26803 - JSC Evex Hospitals
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Mkhatvari
Facility Name
26801 - LTD Hospital Service
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalva Arveladze
Facility Name
26802 - LTD Emergency Cardiology Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vakhtang Chumburidze
Facility Name
26804 - JSC Eristavi National Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lali Tsirdava
Facility Name
79209 - Hacettepe University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serhat Unal
Facility Name
79202 - Ankara University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismail Balik
Facility Name
79207 - Akdeniz University Faculty of Medicine
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ata Yalcin
Facility Name
79212 - Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Kemal Celen
Facility Name
79201 - Liv Hospital Vadistanbul
City
Istanbul
ZIP/Postal Code
34396
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G Dilek Arman
Facility Name
79205 - Goztepe Suleyman Yalcin City Hospital
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Sargin
Facility Name
79203 - Acibadem Atakent Hospital
City
Istanbul
ZIP/Postal Code
61080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftihar Koksal
Facility Name
79213 - Ege University Faculty of Medicine
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuncay Goksel
Facility Name
79208 - Izmir Dr. Suat Seren Pulmonary Hospital
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulru Polat
Facility Name
79210 - Dokuz Eylul University Faculty of Medicine
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukran Kose
Facility Name
79204 - Kocaeli University Faculty of Medicine
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sila Akhan
Facility Name
79206 - Ondokuz Mayis University Faculty of Medicine
City
Samsun
ZIP/Postal Code
55270
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurhan Koksal
Facility Name
79211 - Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gurdal Yilmaz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.
IPD Sharing Time Frame
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
IPD Sharing Access Criteria
Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Learn more about this trial

A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Quadrivalent Influenza Vaccine Compared to a Non-adjuvanted Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age

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