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 |
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.
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.
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