Status:
COMPLETED
Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. This protocol posting deals wi...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
- Written informed consent obtained from the subject.
- Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- Female subjects must be of non-childbearing potential.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female, female planning to become pregnant or planning to discontinue contraceptive precautions.
Key Trial Info
Start Date :
October 6 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2009
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00760617
Start Date
October 6 2008
End Date
May 15 2009
Last Update
August 17 2018
Active Locations (25)
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1
GSK Investigational Site
Güglingen, Baden-Wurttemberg, Germany, 74363
2
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68161
3
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, Germany, 73635
4
GSK Investigational Site
Weinheim, Baden-Wurttemberg, Germany, 69469