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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2014
End Date:April 2015

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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.

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.

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.

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.
We found this trial at
33
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Meridian, ID
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Austin, TX
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Binghamton, NY
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Bristol, TN
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Charlotte, North Carolina 28207
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Huntsville, AL
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Jacksonville, FL
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Jefferson City, Tennessee 37760
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Methuen, MA
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Mishawaka, IN
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Mount Pleasant, South Carolina 29464
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Wilmington, North Carolina 28401
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Witchita, KS
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