A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age

NCT05044195 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V118_23
• Study Type: interventional
• Target: 2,044
• Locations: 3 countries
• Sites: 29

Brief Summary

This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.

Conditions

Influenza, Human

Keywords

Influenza, Vaccine, MF59 adjuvant

Outcome Measures

Primary Outcomes (3)

• Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.

  Day 22

• Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.

  Day 1 to Day 22

• Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.

  Day 22

Secondary Outcomes (8)

• Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  Day 181

• Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  Day 1 to Day 181

• Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  Day 1 to Day 181

• Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  Day 1 to Day 181

• Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains

  Day 1 to Day 181

Other Outcomes (3)

• Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)

  Day 22

• Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)

  Day 22

• Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)

  Day 22

Study Arms (2)

aQIV

EXPERIMENTAL

Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains

Biological: aQIV

Comparator QIV

ACTIVE COMPARATOR

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

Biological: Comparator QIV

Interventions

aQIV BIOLOGICAL

Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1

aQIV

Comparator QIV BIOLOGICAL

Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1

Comparator QIV

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent
• Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
• Individuals who can comply with study procedures including follow-up
• Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination

You may not qualify if:

• Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination
• Progressive, unstable or uncontrolled clinical conditions
• Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
• History of any medical condition considered an AESI
• Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
• Abnormal function of the immune system resulting from:
• Clinical conditions
• Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to ≥20 mg/day of prednisone 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 is also permitted
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent
• Received immunoglobulins or any blood products within 180 days prior to informed consent
• Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period
• Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination
• Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination
• Acute (severe) febrile illness

Sponsors & Collaborators

• Seqirus: lead

Study Sites (29)

84013 Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

84007 Alliance for Multispecialty Research

Tempe, Arizona, 85281, United States

Location

84005 JEM Research Institute

Atlantis, Florida, 33462, United States

Location

84010 Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

84001 Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

84003 Meridian Clinical Research

Sioux City, Iowa, 51106, United States

Location

84006 Alliance for Multispecialty Research

Kansas City, Missouri, 64114, United States

Location

84009 Meridian Clinical Research

Lincoln, Nebraska, 68510, United States

Location

84002 Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

84004 Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

84008 United Medical Associates

Binghamton, New York, 13901, United States

Location

84011 Meridian Clinical Research

Endwell, New York, 13760, United States

Location

23302 Vee Family Doctors Centre

Paide, Estonia

Location

23301 Innomedica OÜ - Outpatient

Tallinn, Estonia

Location

23303 Al Mare Perearstikeskus OÜ

Tallinn, Estonia

Location

23304 Merelahe Family Doctors Centre

Tallinn, Estonia

Location

23306 Center for Clinical and Basic Research

Tallinn, Estonia

Location

23305 Clinical Research Center - Vaccine Trials

Tartu, Estonia

Location

27602 Klinische Forschung Berlin

Berlin, Germany

Location

27603 Emovis GmbH

Berlin, Germany

Location

27608 Klinische Forschung Dresden GmbH

Dresden, Germany

Location

27609 IKF Pneumologie GmbH & Co. KG

Frankfurt, Germany

Location

27611 Siteworks GmbH

Fulda, Germany

Location

27601 Klinische Forschung Hamburg GmbH

Hamburg, Germany

Location

27605 Clinical Research Hamburg GmbH

Hamburg, Germany

Location

27604 Klinische Forschung Hannover-Mitte GmbH

Hanover, Germany

Location

27607 Siteworks GmbH

Hanover, Germany

Location

27606 SIBAmed GmbH & Co KG

Leipzig, Germany

Location

27610 Studienzentrum Leitz Triderm

Stuttgart, Germany

Location

MeSH Terms

Conditions

Influenza, Human

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 Manager
• Organization: Seqirus

seqirus.clinicaltrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Program Director

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 14, 2021
• Study Start: September 30, 2021
• Primary Completion: January 18, 2022
• Study Completion: September 9, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
• Access Criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.

Locations

ES (6); DE (11); US (12)