Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 6/10/2018 |
Start Date: | June 2, 2008 |
End Date: | March 26, 2009 |
Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
The purpose of the study is to compare the safety of & immune response to a single dose of
GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,
egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,
egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of
the protocol
- A male or non-pregnant, non-lactating female between 18 and 49 years of age at the
time of vaccination
- Access to a telephone for scheduled follow-up telephone contacts
- Ability to provide written informed consent
- Healthy subjects as established by medical history and physical 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 and continue such precautions for 2 months after receipt of the study
vaccine. All women will have a pregnancy test on the day of vaccination.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the dose of study vaccine, or planned use
during the study period
- Receipt of systemic glucocorticoids within 30 days of study enrollment
- Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other
than glucocorticoids) or irradiation within 6 months prior to study enrollment or
planned administration during the study period
- Administration of immunoglobulins and/or blood products within 3 months prior to study
enrollment or planned administration during the study period
- Previous vaccination against influenza (2007-2008 influenza season)
- History of anaphylactic or other allergic reaction to influenza vaccine, any other
vaccine, or any vaccine component or excipient
- History of Guillain-Barre Syndrome (GBS)
- Acute disease, febrile illness, or upper respiratory infection at screening.
- History of splenectomy
- Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or
immunosuppressive condition (including human immunodeficiency virus [HIV]) based on
medical history and physical examination
- Acquired or congenital coagulation disorders or known thrombocytopenia
- Current treatment with warfarin or heparin derivatives
- Known use of an analgesic or antipyretic medication within 12 hours prior to treatment
for the purposes of prophylaxis of adverse events
- Any medical condition for which the US Advisory Committee on Immunization Practices
recommends vaccination against influenza
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