Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

NCT03314662 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V118_20
• Study Type: interventional
• Target: 1,778
• Locations: 1 country
• Sites: 20

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (4)

• Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.

  The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.

  Day 22

• Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis

  The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>= 1:40 or a pre-vaccination HI titer \>= 1:10 and a \>= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.

  Day 22

• Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.

  The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%.

  Day 22

• Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.

  The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%.

  Day 22

Secondary Outcomes (7)

• Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains

  Day 1 and Day 22

• Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains

  Day 22/Day 1

• Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains

  Day 1 and Day 22

• Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains

  Day 22

• Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination

  Day 1 through Day 7

Study Arms (3)

aQIV

EXPERIMENTAL

MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.

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

aTIV-1

EXPERIMENTAL

Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.

Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)

aTIV-2

EXPERIMENTAL

MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.

Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)

Interventions

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

The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.

aQIV

Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) BIOLOGICAL

The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.

aTIV-1

MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2) BIOLOGICAL

The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).

aTIV-2

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (20)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Paradigm clinical Research Centers, Inc

Redding, California, 96001, United States

Location

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, 33134, United States

Location

Meridan Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates, LLC - An AMR Company

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC - An AMR Company

Wichita, Kansas, 67207, United States

Location

Center for Pharmaceutical Research, LLC

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• 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.

  PMID: 31635976 DERIVED

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 Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

Phone: 1-855-358-8966

Study Officials

• Clinical Scientist

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is designed as a double-blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: October 17, 2017
• Primary Completion: December 11, 2017
• Study Completion: May 17, 2018
• Last Updated: July 22, 2020
• Results First Posted: July 22, 2020

Record last verified: 2020-07

Locations

US (20)