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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290509
• Other study ID #: PSC16
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2014
• Last updated: October 26, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Protein Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Flublok Quadrivalent
Intramuscular injection of study vaccine
• Inactivated Influenza Vaccine (IIV4)
Intramuscular injection of study vaccine

Locations

Country	Name	City	State
United States	Benchmark Reseach	Austin	Texas
United States	Meridian Research	Bellevue	Nebraska
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Meridian Research	Dakota Dunes	South Dakota
United States	Benchmark Research - Fort Worth	Fort Worth	Texas
United States	Benchmark Research	Metairie	Louisiana
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Benchmark Research - Sacramento	Sacramento	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Protein Sciences Corporation	Department of Health and Human Services, INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with seroconversion	Seroconversion rate and GMT HAI titers 28 days post-vaccination	Days 0-28	No
Secondary	Number of Participants with Systemic and injection site reactogenicity	Incidence and severity of solicited adverse events of reactogenicity	Days 0-7	Yes
Secondary	Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)	Incidence of Serious and/or Medically-Attended Adverse events	Six months post-vaccination	Yes