Clinical trial NCT02214225: A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Official title: A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 3484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.

Detailed description: This multicenter, randomized, double-blinded study was conducted during the 2014-2015 Northern Hemisphere influenza immunization season to evaluate the non-inferior immune response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day on-study period with a six month safety follow-up.

Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females aged ≥ 18 years at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the On-study period. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
* Vaccination against influenza in the previous 6 months.
* Known history of Guillain-Barré Syndrome or other demyelinating disease.
* Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
* A clinically significant medical condition.
* Pregnant or lactating females.

Primary outcomes:
measure: Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).
timeFrame: 21 days after vaccination.
measure: The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.
timeFrame: 21 days after vaccination.
Secondary outcomes:
measure: Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).
timeFrame: 21 days after vaccination.
measure: The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).
timeFrame: 21 days after vaccination.
measure: Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).
timeFrame: 21 days after vaccination.
measure: Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)
timeFrame: 21 days after vaccination.
measure: Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.
timeFrame: 21 days after vaccination.
measure: Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.
timeFrame: 21 days after vaccination.
measure: Seroprotection Rates Prevaccination and Postvaccination.
timeFrame: 21 days after vaccination.
measure: Seroconversion Rates
timeFrame: 21 days after vaccination.
measure: The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).
timeFrame: For 7 days following vaccination.
measure: The Frequency of Cellulitis-like Reaction and Cellulitis.
timeFrame: For 28 days following vaccination.
measure: The Frequency and Severity of Unsolicited AEs.
timeFrame: For 28 days following vaccination.
measure: The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.
timeFrame: For 6 months following vaccination.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 296
state: Alabama
city: Los Angeles
country: United States
facility: Site 286
state: California
city: San Diego
country: United States
facility: Site 315
state: California
city: Milford
country: United States
facility: Site 301
state: Connecticut
city: Jacksonville
country: United States
facility: Site 297
state: Florida
city: Melbourne
country: United States
facility: Site 293
state: Florida
city: Savannah
country: United States
facility: Site 292
state: Georgia
city: Meridian
country: United States
facility: Site 289
state: Idaho
city: Peoria
country: United States
facility: Site 294
state: Illinois
city: Mishawaka
country: United States
facility: Site 295
state: Indiana
city: Witchita
country: United States
facility: Site 317
state: Kansas
city: Rockville
country: United States
facility: Site 291
state: Maryland
city: Methuen
country: United States
facility: Site 310
state: Massachusetts
city: Saint Louis
country: United States
facility: Site 287
state: Missouri
city: Bellevue
country: United States
facility: Site 316
state: Nebraska
city: Las Vegas
country: United States
facility: Site 298
state: Nevada
city: Binghamton
country: United States
facility: Site 285
state: New York
city: Rochester
country: United States
facility: Site 313
state: New York
city: Charlotte
country: United States
facility: Site 302
state: North Carolina
city: Raleigh
country: United States
facility: Site 306
state: North Carolina
city: Wilmington
country: United States
facility: Site 309
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 305
state: North Carolina
city: Oklahoma City
country: United States
facility: Site 299
state: Oklahoma
city: Mount Pleasant
country: United States
facility: Site 307
state: South Carolina
city: Bristol
country: United States
facility: Site 308
state: Tennessee
city: Jefferson City
country: United States
facility: Site 311
state: Tennessee
city: Knoxville
country: United States
facility: Site 312
state: Tennessee
city: Knoxville
country: United States
facility: Site 304
state: Tennessee
city: Austin
country: United States
facility: Site 283
state: Texas
city: Forth Worth
country: United States
facility: Site 282
state: Texas
city: San Angelo
country: United States
facility: Site 288
state: Texas
city: Salt Lake City
country: United States
facility: Site 300
state: Utah
city: Charlottesville
country: United States
facility: Site 303
state: Virginia
Study officials:
affiliation: Seqirus
name: bioCSL Pty Ltd Clinical Program Director
role: STUDY_DIRECTOR
References:
citation: Treanor JT, Albano FR, Sawlwin DC, Graves Jones A, Airey J, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study. Vaccine. 2017 Apr 4;35(15):1856-1864. doi: 10.1016/j.vaccine.2017.02.066. Epub 2017 Mar 13.