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
672
mi
from 02139
Wilmington, NC
Click here to add this to my saved trials
1695
mi
from 02139
Austin, TX
Click here to add this to my saved trials
1276
mi
from 02139
Bellevue, NE
Click here to add this to my saved trials
246
mi
from 02139
Binghamton, NY
Click here to add this to my saved trials
712
mi
from 02139
Bristol, TN
Click here to add this to my saved trials
Charlotte, North Carolina 28207
719
mi
from 02139
Charlotte, NC
Click here to add this to my saved trials
490
mi
from 02139
Charlottesville, VA
Click here to add this to my saved trials
1578
mi
from 02139
Forth Worth, TX
Click here to add this to my saved trials
986
mi
from 02139
Huntsville, AL
Click here to add this to my saved trials
1015
mi
from 02139
Jacksonville, FL
Click here to add this to my saved trials
Jefferson City, Tennessee 37760
789
mi
from 02139
Jefferson City, TN
Click here to add this to my saved trials
815
mi
from 02139
Knoxville, TN
Click here to add this to my saved trials
815
mi
from 02139
Knoxville, TN
Click here to add this to my saved trials
2377
mi
from 02139
Las Vegas, NV
Click here to add this to my saved trials
2588
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
1121
mi
from 02139
Melbourne, FL
Click here to add this to my saved trials
2261
mi
from 02139
Meridian, ID
Click here to add this to my saved trials
25
mi
from 02139
Methuen, MA
Click here to add this to my saved trials
127
mi
from 02139
Milford, CT
Click here to add this to my saved trials
773
mi
from 02139
Mishawaka, IN
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
816
mi
from 02139
Mount Pleasant, SC
Click here to add this to my saved trials
1490
mi
from 02139
Oklahoma City, OK
Click here to add this to my saved trials
960
mi
from 02139
Peoria, IL
Click here to add this to my saved trials
608
mi
from 02139
Raleigh, NC
Click here to add this to my saved trials
334
mi
from 02139
Rochester, NY
Click here to add this to my saved trials
389
mi
from 02139
Rockville, MD
Click here to add this to my saved trials
1033
mi
from 02139
Saint Louis, MO
Click here to add this to my saved trials
2091
mi
from 02139
Salt Lake City, UT
Click here to add this to my saved trials
1774
mi
from 02139
San Angelo, TX
Click here to add this to my saved trials
2576
mi
from 02139
San Diego, CA
Click here to add this to my saved trials
902
mi
from 02139
Savannah, GA
Click here to add this to my saved trials
652
mi
from 02139
Winston-Salem, NC
Click here to add this to my saved trials
1446
mi
from 02139
Witchita, KS
Click here to add this to my saved trials