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

Protein Sciences

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Flublok Quadrivalent; Biological: Inactivated Influenza Vaccine (IIV4)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02290509

PSC16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,350 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,350 participants in 2 patient groups

Flublok Quadrivalent Influenza Vaccine

Experimental group

Description:

Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL

Treatment:

Biological: Flublok Quadrivalent

Inactivated Influenza Vaccine (IIV4)

Active Comparator group

Description:

Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.

Treatment:

Biological: Inactivated Influenza Vaccine (IIV4)