Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age

Protein Sciences Corporation1,350 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,350

Conditions

Influenza

Interventions

Flublok QuadrivalentBIOLOGICAL

Intramuscular injection of study vaccine

Inactivated Influenza Vaccine (IIV4)BIOLOGICAL

Intramuscular injection of study vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Benchmark Research - Sacramento

Sacramento, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Meridian Clinical Research

Savannah, Georgia, United States

Outcomes

Primary Outcomes

Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine

Seroconversion is defined as: Either a pre vaccination titer \< 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.

Time frame: Day 28 after final vaccination

Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine

Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.

Time frame: Day 0 and Day 28 after final vaccination

Secondary Outcomes

Number of Participants With Systemic and Injection Site Reactogenicity

Time frame: Days 0-7

Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)

Time frame: Six months post-vaccination

Data from ClinicalTrials.gov

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