Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:9/23/2018
Start Date:August 12, 2011
End Date:September 28, 2012

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Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A,
prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when
administered up to 5 years following production.


Inclusion Criteria:

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

- A male or female 18 to 64 years of age at the time of the first vaccination.

- Written informed consent obtained from the subject.

- Stable general health as established by medical history and clinical examination
before entering into the study.

- Subject access to a consistent means of telephone contact, 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 for 2 months after completion of
the vaccination series.

Exclusion Criteria:

- Previous vaccination at any time with an H5N1 vaccine.

- 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.

- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.

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

- Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on
the scheduled date of first dose.

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

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

- Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any
other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical,
intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors
or imiquimod are allowed.

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

- 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 dosing, are eligible. Persons receiving prophylactic antiplatelet
medications, and without a clinically-apparent bleeding tendency, are eligible.

- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6
weeks of receipt of seasonal influenza vaccine.

- Administration of an inactivated or a live, attenuated seasonal influenza vaccine
within 14 days before the first study vaccine dose, or of any other vaccine(s) not
foreseen by the study protocol within 30 days before the first study vaccine dose.

- Planned administration of any vaccine(s) not foreseen by the study protocol through
completion of the Day 42 visit.

- Any known or suspected allergy to any constituent of influenza vaccines, or history of
severe reaction to a previous influenza vaccination.

- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result
prior to the first study vaccine dose.

- Lactating or nursing women.
We found this trial at
1
site
Mesa, Arizona 85206
834
mi
from
Mesa, AZ
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