Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:6/20/2018
Start Date:August 22, 2012
End Date:March 19, 2014

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An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of
different formulations of a two-dose primary series and booster vaccination of monovalent
Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18
to 64 years of age.


Inclusion Criteria:

- Male or female adults from 18 to 64 years of age (inclusive) at time of first study
vaccination.

- Written informed consent obtained from the subject.

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

- Healthy subjects as established by medical history and physical examination.

- Body weight of at least 110 lbs (49.9 kg).

- 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 (i.e., a common-use phone serving multiple rooms or apartments).

- Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as current tubal ligation, hysterectomy,
ovariectomy or post-menopause.

- Female subjects of childbearing potential may be enrolled in the study, if they have
practiced adequate contraception for 30 days prior to vaccination, and have a negative
pregnancy test on the day of vaccination, and agree to continue to practice adequate
contraception until 2 months after booster dose administration.

Exclusion Criteria:

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

- Presence or evidence of substance abuse.

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

- Persons with a history of cancer who are disease-free without treatment for three
years or more are eligible.

- Persons with a history of histologically-confirmed basal cell carcinoma of the
skin successfully treated with local excision only are excepted and may enroll,
but other histologic types of skin cancer are exclusionary.

- Women who are disease-free three years or more after treatment for breast cancer
and receiving long-term prophylaxis may enroll.

- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), 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 (HIV) infection (no laboratory testing
required).

- Receipt of systemic glucocorticoids (e.g., prednisone ≥ 10 mg/day for more than 14
consecutive days) within 30 days prior to the first dose of study vaccine, or any
other cytotoxic, immunosuppressive or immune-modifying drugs within 365 days of study
enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical
calcineurin inhibitors or imiquimod are allowed.

- Any significant disorder of coagulation or treatment with warfarin derivatives or
heparin. Persons receiving individual doses of low molecular weight heparin outside of
24 hours prior to vaccination are eligible. Persons receiving prophylactic
antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent
bleeding tendency, are eligible.

- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of
receipt of prior seasonal or pandemic influenza vaccine.

- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine
within 30 days before the first dose of study vaccine/product.

- Planned administration of any vaccine other than the study vaccine/product before
blood sampling at the Day 42 visit.

- Previous administration of any H9 vaccine or physician-confirmed H9 disease.

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

- Receipt of any immunoglobulins and/or any blood products within 90 days before study
enrolment or planned administration of any of these products during the study period.

- Any known or suspected allergy to any constituent of influenza vaccines or component
used in the manufacturing process of the study vaccine including 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 (β-hCG) test
result before the first vaccination.

- Lactating or nursing women.

- Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.
We found this trial at
4
sites
Sherbrooke, Quebec
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Sherbrooke,
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Austin, Texas 78705
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Austin, TX
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Edison, New Jersey
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Edison, NJ
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Miami, Florida 33136
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Miami, FL
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