A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/23/2018
Start Date:October 1, 2010
End Date:June 24, 2011

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Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Quadrivalent Influenza Vaccine FLU Q-QIV (GSK2282512A) When Administered Intramuscularly to Adults 18 Years of Age and Older

This study is designed to test the immunogenicity and safety of an investigational influenza
vaccine, in adults compared to two other influenza vaccines.

This study will also evaluate the lot-to-lot consistency of three vaccine lots.


Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol

- A male or female 18 years of age or older, in stable health, as established by medical
history and physical examination before entering into the study.

- Written informed consent obtained from the subject.

- Access to a consistent means of telephone contact, which may be either in the home or
at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user
device.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- - has practiced adequate contraception for 30 days prior to vaccination, and

- - has a negative pregnancy test on the day of vaccination, and

- - has agreed to continue adequate contraception during the entire treatment period and
for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Use of an investigational / non-registered product other than the study vaccines
within 30 days before study vaccination or planned use during study period.

- Planned administration or administration of a licensed vaccine within 30 days before
study vaccination.

- Prior receipt of 2010/2011 influenza vaccine.

- Receipt of any investigational or approved influenza vaccine within six months of the
first study visit.

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

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.

- History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated
influenza virus vaccine.

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

- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional
abnormality, based on history and physical examination.

- Presence of significant uncontrolled chronic medical or neuropsychiatric illness,
based on history and physical examination

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

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

- Chronic administration of immunosuppressants or other immune-modifying drugs within 3
months prior to the first vaccine/product dose.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

- Pregnant or lactating female.

- Fever at the time of enrolment.

- Acute disease at the time of enrolment

- Any other condition which, in the opinion of the Investigator, prevents the subject
from participating in the study.
We found this trial at
7
sites
Coquitlam, British Columbia
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Coquitlam,
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Elkridge, Maryland 21075
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from
Elkridge, MD
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Endwell, New York 13760
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Endwell, NY
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Jefferson Hills, Pennsylvania 15025
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Jefferson Hills, PA
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Mesa, Arizona 85206
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Mesa, AZ
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Wenatchee, Washington 98801
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from
Wenatchee, WA
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Wichita, Kansas 67207
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from
Wichita, KS
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