Clinical trial NCT02290509: Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
Official title: Double-Blind, Randomized, Active-Controlled Comparison of the Immunogenicity and Safety of Flublok® Quadrivalent Versus IIV4 in Healthy, Medically Stable Adults 18-49 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Protein Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Department of Health and Human Services
First posted: 2014-11-14
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.

Detailed description: As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.

Eligibility criteria: Inclusion Criteria:

* Ambulatory, in good health or medically stable
* Able to understand and comply with planned study procedures
* Provide written informed consent
* Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)

Exclusion Criteria:

* Prior serious or severe reaction to influenza vaccine
* Known contraindication to either study vaccine
* Receipt of any other influenza vaccine within 180 days prior to enrollment
* Plan to receive another licensed influenza or other vaccine during the duration of this study
* Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
* Underlying disease or therapeutic intervention that might adversely affect the immune response
* Plans to participate in any investigation involving an investigational product during this study.
* Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
* Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation

Primary outcomes:
measure: Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
timeFrame: Day 28 after final vaccination
measure: Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
timeFrame: Day 0 and Day 28 after final vaccination
Secondary outcomes:
measure: Number of Participants With Systemic and Injection Site Reactogenicity
timeFrame: Days 0-7
measure: Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
timeFrame: Six months post-vaccination
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Benchmark Research - Sacramento
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Bellevue
country: United States
facility: Meridian Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Dakota Dunes
country: United States
facility: Meridian Research
state: South Dakota
city: Austin
country: United States
facility: Benchmark Reseach
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth
state: Texas
Study officials:
affiliation: Benchmark Research, Fort Worth, TX
name: William Seger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Muse D, Cox MMJ. Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. J Infect Dis. 2017 Dec 5;216(10):1219-1226. doi: 10.1093/infdis/jix478.