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

Completed · Phase 3

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT02214225

Run by

Seqirus

People needed

3484

Starts

2014-08-01

Expected to finish

2015-04-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Site 296 — Huntsville, Alabama, United States
• Site 286 — Los Angeles, California, United States
• Site 315 — San Diego, California, United States
• Site 301 — Milford, Connecticut, United States
• Site 297 — Jacksonville, Florida, United States
• Site 293 — Melbourne, Florida, United States
• Site 292 — Savannah, Georgia, United States
• Site 289 — Meridian, Idaho, United States
• Site 294 — Peoria, Illinois, United States
• Site 295 — Mishawaka, Indiana, United States
• Site 317 — Witchita, Kansas, United States
• Site 291 — Rockville, Maryland, United States
• Site 310 — Methuen, Massachusetts, United States
• Site 287 — St Louis, Missouri, United States
• Site 316 — Bellevue, Nebraska, United States
• Site 298 — Las Vegas, Nevada, United States
• Site 285 — Binghamton, New York, United States
• Site 313 — Rochester, New York, United States
• Site 302 — Charlotte, North Carolina, United States
• Site 306 — Raleigh, North Carolina, United States
• Site 309 — Wilmington, North Carolina, United States
• Site 305 — Winston-Salem, North Carolina, United States
• Site 299 — Oklahoma City, Oklahoma, United States
• Site 307 — Mt. Pleasant, South Carolina, United States
• Site 308 — Bristol, Tennessee, United States

Full record on ClinicalTrials.gov

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