Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
- Conditions
- Influenza
- Interventions
- Biological: Flublok QuadrivalentBiological: Inactivated Influenza Vaccine (IIV4)
- Registration Number
- NCT02290509
- Lead Sponsor
- Protein Sciences Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1350
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flublok Quadrivalent Influenza Vaccine Flublok Quadrivalent 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 Inactivated Influenza Vaccine (IIV4) Inactivated Influenza Vaccine (IIV4) 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.
- Primary Outcome Measures
Name Time Method Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine Day 28 after final vaccination 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.
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine Day 0 and Day 28 after final vaccination 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Systemic and Injection Site Reactogenicity Days 0-7 Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) Six months post-vaccination
Trial Locations
- Locations (8)
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Benchmark Research - Sacramento
🇺🇸Sacramento, California, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Benchmark Research
🇺🇸Metairie, Louisiana, United States
Meridian Research
🇺🇸Dakota Dunes, South Dakota, United States
Benchmark Reseach
🇺🇸Austin, Texas, United States
Benchmark Research - Fort Worth
🇺🇸Fort Worth, Texas, United States