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

Use our guide to learn which trials are right for you!

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
sites
Wilmington, North Carolina 28401
484
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
679
mi
from 43215
Bellevue, NE
Click here to add this to my saved trials
398
mi
from 43215
Binghamton, NY
Click here to add this to my saved trials
239
mi
from 43215
Bristol, TN
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
278
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
941
mi
from 43215
Forth Worth, TX
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Jefferson City, Tennessee 37760
266
mi
from 43215
Jefferson City, TN
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
832
mi
from 43215
Melbourne, FL
Click here to add this to my saved trials
1725
mi
from 43215
Meridian, ID
Click here to add this to my saved trials
642
mi
from 43215
Methuen, MA
Click here to add this to my saved trials
529
mi
from 43215
Milford, CT
Click here to add this to my saved trials
202
mi
from 43215
Mishawaka, IN
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
524
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
348
mi
from 43215
Peoria, IL
Click here to add this to my saved trials
371
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
320
mi
from 43215
Rockville, MD
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1136
mi
from 43215
San Angelo, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
561
mi
from 43215
Savannah, GA
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials
825
mi
from 43215
Witchita, KS
Click here to add this to my saved trials