Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:October 4, 2010
End Date:June 6, 2011

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Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.

This study is designed to assess the safety and immunogenicity of a GSK Biologicals'
investigational vaccine GSK2321138A in adults 18 years old and older. This study is also
designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be
double blind for all groups except for the GSK2604409A Group which will be open.


Inclusion Criteria:

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

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

- Written informed consent obtained from the subject.

- Healthy subjects or those with chronic well-controlled disease as established by
physical examination before entering into the study.

- 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 urine 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 any investigational or non-registered product other than the study vaccine
within 30 days preceding the dose of the study vaccine or planned use during the study
period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
three months prior to enrolment in this study or planned administration during the
study period.

- Administration of an influenza vaccine during the 6 months preceding entry into the
study.

- Planned administration / administration of a vaccine not foreseen by the study
protocol within 30 days before vaccination and up to Day 21.

- Any contra-indication to intramuscular administration of the influenza vaccines.

- History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine,
history of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.

- Any administration of a long-acting immune-modifying drug within 3 months before study
start, or planned administration during the study period.

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

- Acute disease and/or fever at the time of enrolment.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.

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

- Administration of immunoglobulins and/or any blood products within the three months
prior to the enrolment in this study, or planned during the study.

- History of chronic alcohol consumption and/or drug abuse.

- Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study

- Pregnant or lactating female.
We found this trial at
11
sites
Milford, Massachusetts 01757
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Milford, MA
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Chandler, Arizona 85224
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Chandler, AZ
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Columbia, Maryland 21044
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Columbia, MD
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Erie, Pennsylvania 16507
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Erie, PA
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Lexington, Kentucky 40504
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Lexington, KY
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Miami, Florida 33136
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Miami, FL
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Nashville, Tennessee 37203
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Nashville, TN
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Newton, Kansas 67114
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Newton, KS
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Salisbury, North Carolina 28114
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Salisbury, NC
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Tuebingen, Baden-Wuerttemberg 72074
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Tuebingen,
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