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

NCT ID: NCT02290509

Last Updated: 2016-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Flublok Quadrivalent

Intervention Type BIOLOGICAL

Intramuscular injection of study vaccine

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.

Group Type ACTIVE_COMPARATOR

Inactivated Influenza Vaccine (IIV4)

Intervention Type BIOLOGICAL

Intramuscular injection of study vaccine

Interventions

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Flublok Quadrivalent

Intramuscular injection of study vaccine

Intervention Type BIOLOGICAL

Inactivated Influenza Vaccine (IIV4)

Intramuscular injection of study vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Department of Health and Human Services

FED

Sponsor Role collaborator

Protein Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Seger, MD

Role: PRINCIPAL_INVESTIGATOR

Benchmark Research, Fort Worth, TX

Locations

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Benchmark Research - Sacramento

Sacramento, California, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Meridian Clinical Research

Savannah, Georgia, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Benchmark Research

Metairie, Louisiana, United States

Site Status

Meridian Research

Bellevue, Nebraska, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

Meridian Research

Dakota Dunes, South Dakota, United States

Site Status

Benchmark Reseach

Austin, Texas, United States

Site Status

Benchmark Research - Fort Worth

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Muse D, Cox MMJ. Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. J Infect Dis. 2017 Dec 5;216(10):1219-1226. doi: 10.1093/infdis/jix478.

Reference Type DERIVED
PMID: 28968871 (View on PubMed)

Other Identifiers

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PSC16

Identifier Type: -

Identifier Source: org_study_id