Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:January 23, 2008
End Date:March 19, 2009

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

A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to
characterize the immunogenicity & safety of the investigation vaccination regimen of GSK
1557484A vaccine given to adults aged ≥18 years.


Inclusion Criteria:

- A male or female 18 years of age or greater at the time of the first vaccination.

- Written informed consent obtained from the subject.

- Among 18 to 49 year old subjects, good general health as established by medical
history and clinical examination before entering into the study.

- Among subjects > 49 years of age, stable health status within 1 month prior to
enrollment.

- Access to a consistent means of telephone contact.

- Comprehension of the study requirements, ability to comprehend and comply with
procedures for collection of short- and long-term safety data, expressed availability
for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

- Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if
clinically stable, are deemed by the investigator to render the potential
subjectunable/unlikely to provide accurate safety reports.

- Diagnosed with cancer, or treatment for cancer, within 3 years.

- An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the
scheduled date of first vaccination.

- Any confirmed or suspected immunosuppressive or immunodeficient condition including
history of human immunodeficiency virus infection.

- Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other
cytotoxic or immunosuppressive drug within 6 months of study enrollment.

- Any significant disorder of coagulation or treatment with Coumadin derivatives or
heparin.

- Administration of any vaccines within 30 days before study enrollment.

- Previous administration of any H5N1 vaccine.

- Use of any investigational or non-registered product or planned participation in
another investigational study within 30 days prior to study enrollment, or during the
364 days following the first test article dose. Use of any investigational or
non-registered product with immunosuppressive properties is exclusionary at any time
during the trial.

- Receipt of any immunoglobulins and/or any blood products within 3 months of study
enrollment or planned administration of any of these products during the study period.

- Any known or suspected allergy to any constituent of influenza vaccines; a history of
anaphylactic-type reaction to consumption of eggs; or a history of severe adverse
reaction to a previous influenza vaccine.

- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
prior to either vaccination.

- Lactating or nursing.

- Women of child bearing potential who lack a history of reliable contraceptive
practices. The provision of this history does NOT replace the requirement to perform,
and obtain negative results in pregnancy urine tests prior to treatments.

- Known use of an analgesic or antipyretic medication within 12 hours prior to first
treatment.
We found this trial at
31
sites
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Edison, New Jersey
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Erie, Pennsylvania 16507
?
mi
from
Erie, PA
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Halifax, Nova Scotia
?
mi
from
Halifax,
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lenexa, Kansas 66215
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Melbourne, Florida 32935
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Missoula, Montana 59807
?
mi
from
Missoula, MT
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Peoria, Illinois 61636
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Raleigh, North Carolina 27614
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Angelo, Texas 76904
?
mi
from
San Angelo, TX
Click here to add this to my saved trials
South Bend, Indiana 46601
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Stockbridge, Georgia 30281
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
Wichita, Kansas 67207
?
mi
from
Wichita, KS
Click here to add this to my saved trials