NCT02290509

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,350 (actual)
• Sponsor: Protein Sciences Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flublok Quadrivalent	Intramuscular injection of study vaccine
BIOLOGICAL	Inactivated Influenza Vaccine (IIV4)	Intramuscular injection of study vaccine

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-11-14
• Last updated: 2016-10-27
• Results posted: 2016-09-22

Locations

10 sites across 1 country: United States