Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults



Status:Completed
Conditions:Influenza, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:4/21/2016
Start Date:October 2008
End Date:July 2009

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

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

This study is designed to test lot consistency of three different manufacturing lots and to
generate safety and immunogenicity data of the investigational vaccine administered via the
ID route.

Primary Objective:

- To demonstrate lot consistency of the Fluzone ID manufacturing process.

- To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

- To describe the safety profile of subjects who receive of Fluzone ID.

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere
formulation will be administered intradermally (ID) using the Becton Dickinson Micro
Injection System.

Inclusion Criteria :

- Aged 18 to 64 years on the day of vaccination.

- Informed consent form signed and dated.

- Able to attend all scheduled visits and to comply with all trial procedures.

- For women of child bearing potential, avoid becoming pregnant (use of an effective
method of contraception or abstinence) for at least 4 weeks prior to vaccination,
until at least 4 weeks after vaccination.

Exclusion Criteria :

- Known systemic hypersensitivity to any of the vaccine components or history of a
life-threatening reaction to the trial vaccine or to a vaccine containing any of the
same substances.

- For a woman of child-bearing potential: known pregnancy or positive serum/urine
pregnancy test.

- Breast-feeding woman.

- Participation in another clinical trial investigating a vaccine, drug, medical
device, or a medical procedure in the four weeks preceding the trial vaccination.

- Planned participation in another clinical trial during the present trial period.

- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
or long-term systemic corticosteroids therapy

- Chronic illness, at a stage that could interfere with trial conduct or completion, in
the opinion of the investigator.

- Current alcohol abuse or drug addiction that may interfere with the subject's ability
to comply with trial procedures.

- Receipt of blood or blood-derived products in the past 3 months that might interfere
with the assessment of immune response.

- Receipt of any vaccination in the 4 weeks preceding the trial vaccination.

- Planned receipt of any vaccine in the 4 weeks following the trial vaccination.

- Previous vaccination against influenza in the past 6 months with the trial vaccine or
another vaccine.

- Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.

- Subject deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent.

- Neoplastic disease or any hematologic malignancy, (except localized skin or prostate
cancer that is stable at the time of vaccination in the absence of therapy, and
subjects who have a history of neoplastic disease and who have been disease free for
>=5 years).

- Personal or family history of Guillain-Barré Syndrome.
We found this trial at
45
sites
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Bensalem, PA
Click here to add this to my saved trials
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Cary, NC
Click here to add this to my saved trials
?
mi
from
Castellana Gardens, Carolina,
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Endwell, NY
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Galveston, TX
Click here to add this to my saved trials
?
mi
from
Hoover, AL
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Madisonville, KY
Click here to add this to my saved trials
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Milford, CT
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Mt. Pleasant, South Carolina 29464
?
mi
from
Mt. Pleasant, SC
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Rockville, MD
Click here to add this to my saved trials
?
mi
from
Salt Lake, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Angelo, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Springfield, MO
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials