A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

NCT02214225 | Completed Phase 3 Results DMC

• 1 other identifier: CSLCT-QIV-13-01
• Study Type: interventional
• Target: 3,484
• Locations: 1 country
• Sites: 33

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (2)

• Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).

  Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.

  21 days after vaccination.

• The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.

  SCR (defined as the percentage of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.

  21 days after vaccination.

Secondary Outcomes (12)

• Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).

  21 days after vaccination.

• 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).

  21 days after vaccination.

• 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).

  21 days after vaccination.

• 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)

  21 days after vaccination.

• Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.

  21 days after vaccination.

Study Arms (3)

Quadrivalent Influenza Vaccine (QIV)

EXPERIMENTAL

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).

Biological: Quadrivalent Influenza Vaccine (QIV)

Trivalent Influenza Vaccine (TIV-1)

ACTIVE COMPARATOR

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).

Biological: Trivalent Influenza Vaccine (TIV-1)

Trivalent Influenza Vaccine (TIV-2)

ACTIVE COMPARATOR

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season).

Biological: Trivalent Influenza Vaccine (TIV-2)

Interventions

Quadrivalent Influenza Vaccine (QIV) BIOLOGICAL

One 0.5 mL intramuscular dose into the deltoid muscle

Quadrivalent Influenza Vaccine (QIV)

Trivalent Influenza Vaccine (TIV-1) BIOLOGICAL

One 0.5 mL intramuscular dose into the deltoid muscle.

Trivalent Influenza Vaccine (TIV-1)

Trivalent Influenza Vaccine (TIV-2) BIOLOGICAL

One 0.5 mL intramuscular dose into the deltoid muscle.

Trivalent Influenza Vaccine (TIV-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (33)

Site 296

Huntsville, Alabama, 35802, United States

Location

Site 286

Los Angeles, California, 90036, United States

Location

Site 315

San Diego, California, 92108, United States

Location

Site 301

Milford, Connecticut, 06460, United States

Location

Site 297

Jacksonville, Florida, 32207, United States

Location

Site 293

Melbourne, Florida, 32935, United States

Location

Site 292

Savannah, Georgia, 31406, United States

Location

Site 289

Meridian, Idaho, 83642, United States

Location

Site 294

Peoria, Illinois, 61614, United States

Location

Site 295

Mishawaka, Indiana, 46545, United States

Location

Site 317

Witchita, Kansas, 67207, United States

Location

Site 291

Rockville, Maryland, 20850, United States

Location

Site 310

Methuen, Massachusetts, 01844, United States

Location

Site 287

St Louis, Missouri, 63141, United States

Location

Site 316

Bellevue, Nebraska, 68005, United States

Location

Site 298

Las Vegas, Nevada, 89104, United States

Location

Site 285

Binghamton, New York, 13901, United States

Location

Site 313

Rochester, New York, 14642, United States

Location

Site 302

Charlotte, North Carolina, 28209, United States

Location

Site 306

Raleigh, North Carolina, 27609, United States

Location

Site 309

Wilmington, North Carolina, 28401, United States

Location

Site 305

Winston-Salem, North Carolina, 27103, United States

Location

Site 299

Oklahoma City, Oklahoma, 73112, United States

Location

Site 307

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 308

Bristol, Tennessee, 37620, United States

Location

Site 311

Jefferson City, Tennessee, 37760, United States

Location

Site 312

Knoxville, Tennessee, 37912, United States

Location

Site 304

Knoxville, Tennessee, 37938, United States

Location

Site 283

Austin, Texas, 78705, United States

Location

Site 282

Forth Worth, Texas, 76135, United States

Location

Site 288

San Angelo, Texas, 76904, United States

Location

Site 300

Salt Lake City, Utah, 84124, United States

Location

Site 303

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• 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.

  PMID: 28302411 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Seqirus Clinical Trial Disclosure Lead
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

Study Officials

• bioCSL Pty Ltd Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: August 10, 2014
• First Posted: August 12, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 13, 2017
• Results First Posted: February 23, 2016

Record last verified: 2017-01

Locations

US (33)