Clinical trial NCT05044195: 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
Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza, Vaccine, MF59 adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 2044
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the following inclusion criteria:

* 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

Exclusion Criteria:

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:

* 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:

  1. Clinical conditions
  2. 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
  3. 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
* Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to)
* 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
* 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 or household member of study personnel

Primary outcomes:
measure: 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
timeFrame: Day 22
measure: Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
timeFrame: Day 1 to Day 22
measure: 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
timeFrame: Day 22
Secondary outcomes:
measure: 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
timeFrame: Day 181
measure: 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
timeFrame: Day 1 to Day 181
measure: 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
timeFrame: Day 1 to Day 181
measure: 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
timeFrame: Day 1 to Day 181
measure: Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
timeFrame: Day 1 to Day 181
measure: Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
timeFrame: Day 1 through Day 7
measure: Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
timeFrame: Day 1 through Day 22
measure: Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through Day 271
Other outcomes:
measure: 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)
timeFrame: Day 22
measure: 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)
timeFrame: Day 22
measure: 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)
timeFrame: Day 22
Locations:
city: Mobile
country: United States
facility: 84013 Coastal Clinical Research, Inc.
state: Alabama
city: Tempe
country: United States
facility: 84007 Alliance for Multispecialty Research
state: Arizona
city: Atlantis
country: United States
facility: 84005 JEM Research Institute
state: Florida
city: Orlando
country: United States
facility: 84010 Headlands Research Orlando
state: Florida
city: Savannah
country: United States
facility: 84001 Meridian Clinical Research
state: Georgia
city: Sioux City
country: United States
facility: 84003 Meridian Clinical Research
state: Iowa
city: Kansas City
country: United States
facility: 84006 Alliance for Multispecialty Research
state: Missouri
city: Lincoln
country: United States
facility: 84009 Meridian Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: 84002 Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: 84004 Meridian Clinical Research
state: Nebraska
city: Binghamton
country: United States
facility: 84008 United Medical Associates
state: New York
city: Endwell
country: United States
facility: 84011 Meridian Clinical Research
state: New York
city: Paide
country: Estonia
facility: 23302 Vee Family Doctors Centre
city: Tallinn
country: Estonia
facility: 23301 Innomedica OÜ - Outpatient
city: Tallinn
country: Estonia
facility: 23303 Al Mare Perearstikeskus OÜ
city: Tallinn
country: Estonia
facility: 23304 Merelahe Family Doctors Centre
city: Tallinn
country: Estonia
facility: 23306 Center for Clinical and Basic Research
city: Tartu
country: Estonia
facility: 23305 Clinical Research Center - Vaccine Trials
city: Berlin
country: Germany
facility: 27602 Klinische Forschung Berlin
city: Berlin
country: Germany
facility: 27603 Emovis GmbH
city: Dresden
country: Germany
facility: 27608 Klinische Forschung Dresden GmbH
city: Frankfurt
country: Germany
facility: 27609 IKF Pneumologie GmbH & Co. KG
city: Fulda
country: Germany
facility: 27611 Siteworks GmbH
city: Hamburg
country: Germany
facility: 27601 Klinische Forschung Hamburg GmbH
city: Hamburg
country: Germany
facility: 27605 Clinical Research Hamburg GmbH
city: Hannover
country: Germany
facility: 27604 Klinische Forschung Hannover-Mitte GmbH
city: Hannover
country: Germany
facility: 27607 Siteworks GmbH
city: Leipzig
country: Germany
facility: 27606 SIBAmed GmbH & Co KG
city: Stuttgart
country: Germany
facility: 27610 Studienzentrum Leitz Triderm
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: