Clinical trial NCT03314662: Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Official title: A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 1778
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.


Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 65 years old who are healthy or have co-morbidities
* Individuals who or whose legal representative(s) 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 including diary card completion and follow-up

Exclusion Criteria:

* History of behavioral or cognitive impairment or psychiatric condition
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
* Abnormal function of the immune system
* Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
* 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

Additional eligibility criteria may be discussed by contacting the site.

Primary outcomes:
measure: Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
timeFrame: Day 22
measure: Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
timeFrame: Day 22
measure: Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
timeFrame: Day 22
measure: Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
timeFrame: Day 22
Secondary outcomes:
measure: Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
timeFrame: Day 1 and Day 22
measure: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
timeFrame: Day 22/Day 1
measure: Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
timeFrame: Day 1 and Day 22
measure: Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
timeFrame: Day 22
measure: Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
timeFrame: Day 1 through Day 7
measure: Safety Endpoint: Number of Subjects With Unsolicited AEs
timeFrame: Day 1 through Day 22
measure: Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
timeFrame: Day 1 through Day 181
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Redding
country: United States
facility: Paradigm clinical Research Centers, Inc
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida, an AMR Company
state: Florida
city: Savannah
country: United States
facility: Meridan Clinical Research, LLC
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC - An AMR Company
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC - An AMR Company
state: Kansas
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Seqirus
name: Clinical Scientist
role: STUDY_DIRECTOR
References:
citation: Essink B, Fierro C, Rosen J, Figueroa AL, Zhang B, Verhoeven C, Edelman J, Smolenov I. Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults. Vaccine. 2020 Jan 10;38(2):242-250. doi: 10.1016/j.vaccine.2019.10.021. Epub 2019 Oct 18.