Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:19 - Any
Updated:8/2/2018
Start Date:October 9, 2008
End Date:December 15, 2009

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Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

The purpose of this observer-blind clinical trial is to evaluate the safety and
immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly.
Subjects were previously vaccinated (NCT00529516).


Inclusion Criteria:

- A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >=
65 years and 18-41 years of age groups and having received the study vaccine.

- Subjects of whom the investigator believes that they can and will comply with the
requirements of the protocol. Specific attention should be given to the compliance
potential of subjects with suspected or known drug or alcohol abuse.

- Written informed consent obtained from the subject.

- Free of an acute aggravation of the health status as established by medical history
and clinical examination before entering into the study

- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for 2 months
after completion of the vaccination series.

Exclusion Criteria:

- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study.

- Planned administration of a vaccine not foreseen by the study protocol up to 30 days
after vaccination.

- Planned administration of an influenza vaccine other than the study vaccines during
the entire study period.

- Any vaccination against influenza since January 2008 with any seasonal influenza
vaccine.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

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

- History of hypersensitivity to a previous dose of influenza vaccine.

- History of allergy or reactions likely to be exacerbated by any component of the
vaccines.

- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or pre-existing
laboratory screening tests.

- Acute disease at the time of enrolment.

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

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days prior to vaccination, or planned use during the study
period.

- Any medical conditions in which intramuscular injections are contraindicated.

- Pregnant or lactating females.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
We found this trial at
10
sites
Chaska, Minnesota 55318
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Chaska, MN
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Carnegie, Pennsylvania 15106
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Carnegie, PA
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Clearwater, Florida 33759
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Clearwater, FL
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Coral Gables, Florida 33134
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Coral Gables, FL
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Erie, Pennsylvania 16507
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from
Erie, PA
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from
Gent,
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Milford, Massachusetts 01757
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Milford, MA
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Pittsburgh, Pennsylvania 15213
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from
Pittsburgh, PA
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Poughkeepsie, New York 12601
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from
Poughkeepsie, NY
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Somers Point, New Jersey 08244
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Somers Point, NJ
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