Status:
COMPLETED
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2011
Estimated Enrollment :
4659 Patients enrolled
Trial Details
Trial ID
NCT01204671
Start Date
October 4 2010
End Date
June 6 2011
Last Update
September 24 2018
Active Locations (42)
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1
GSK Investigational Site
Chandler, Arizona, United States, 85224
2
GSK Investigational Site
Miami, Florida, United States, 33143
3
GSK Investigational Site
Newton, Kansas, United States, 67114
4
GSK Investigational Site
Lexington, Kentucky, United States, 40509