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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290509
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : September 22, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Syneos Health
Department of Health and Human Services
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Flublok Quadrivalent Biological: Inactivated Influenza Vaccine (IIV4) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Flublok Quadrivalent Influenza Vaccine
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
Biological: Flublok Quadrivalent
Intramuscular injection of study vaccine

Active Comparator: 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.
Biological: Inactivated Influenza Vaccine (IIV4)
Intramuscular injection of study vaccine




Primary Outcome Measures :
  1. Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine [ Time Frame: 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.

  2. Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine [ Time Frame: 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 :
  1. Number of Participants With Systemic and Injection Site Reactogenicity [ Time Frame: Days 0-7 ]
  2. Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs) [ Time Frame: Six months post-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290509


Locations
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United States, California
Benchmark Research - Sacramento
Sacramento, California, United States, 95816
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Nebraska
Meridian Research
Bellevue, Nebraska, United States, 68005
Meridian Clinical Research
Omaha, Nebraska, United States, 68164
United States, South Dakota
Meridian Research
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Benchmark Reseach
Austin, Texas, United States, 78705
Benchmark Research - Fort Worth
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
Protein Sciences Corporation
Syneos Health
Department of Health and Human Services
Investigators
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Principal Investigator: William Seger, MD Benchmark Research, Fort Worth, TX
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT02290509    
Other Study ID Numbers: PSC16
First Posted: November 14, 2014    Key Record Dates
Results First Posted: September 22, 2016
Last Update Posted: October 27, 2016
Last Verified: September 2016