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
1 other identifier
interventional
1,350
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 4, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
September 22, 2016
CompletedOctober 27, 2016
September 1, 2016
7 months
November 4, 2014
June 17, 2016
September 22, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
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.
Day 28 after final vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
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.
Day 0 and Day 28 after final vaccination
Secondary Outcomes (2)
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
Study Arms (2)
Flublok Quadrivalent Influenza Vaccine
EXPERIMENTALIntramuscular 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)
ACTIVE COMPARATORIntramuscular 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.
Interventions
Intramuscular injection of study vaccine
Intramuscular injection of study vaccine
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Protein Sciences Corporationlead
- Syneos Healthcollaborator
- Department of Health and Human Servicescollaborator
Study Sites (10)
Benchmark Research - Sacramento
Sacramento, California, 95816, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
Meridian Research
Bellevue, Nebraska, 68005, United States
Meridian Clinical Research
Omaha, Nebraska, 68164, United States
Meridian Research
Dakota Dunes, South Dakota, 57049, United States
Benchmark Reseach
Austin, Texas, 78705, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135, United States
Related Publications (1)
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.
PMID: 28968871DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa M. Dunkle, M.D., Chief Medical Officer
- Organization
- Protein Sciences Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
William Seger, MD
Benchmark Research, Fort Worth, TX
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2014
First Posted
November 14, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 27, 2016
Results First Posted
September 22, 2016
Record last verified: 2016-09