A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
NCT ID: NCT02214225
Last Updated: 2017-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3484 participants
INTERVENTIONAL
2014-08-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Quadrivalent Influenza Vaccine (QIV)
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).
Quadrivalent Influenza Vaccine (QIV)
One 0.5 mL intramuscular dose into the deltoid muscle
Trivalent Influenza Vaccine (TIV-1)
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).
Trivalent Influenza Vaccine (TIV-1)
One 0.5 mL intramuscular dose into the deltoid muscle.
Trivalent Influenza Vaccine (TIV-2)
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).
Trivalent Influenza Vaccine (TIV-2)
One 0.5 mL intramuscular dose into the deltoid muscle.
Interventions
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Quadrivalent Influenza Vaccine (QIV)
One 0.5 mL intramuscular dose into the deltoid muscle
Trivalent Influenza Vaccine (TIV-1)
One 0.5 mL intramuscular dose into the deltoid muscle.
Trivalent Influenza Vaccine (TIV-2)
One 0.5 mL intramuscular dose into the deltoid muscle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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bioCSL Pty Ltd Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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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
Site 311
Jefferson City, Tennessee, United States
Site 312
Knoxville, Tennessee, United States
Site 304
Knoxville, Tennessee, United States
Site 283
Austin, Texas, United States
Site 282
Forth Worth, Texas, United States
Site 288
San Angelo, Texas, United States
Site 300
Salt Lake City, Utah, United States
Site 303
Charlottesville, Virginia, United States
Countries
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References
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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.
Other Identifiers
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CSLCT-QIV-13-01
Identifier Type: -
Identifier Source: org_study_id
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