Status:
COMPLETED
Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance ...
Detailed Description
This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009. After the analyses for this study were completed, questions arose regarding the integrity of study data from a sing...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A man or woman aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Subjects with residence status allowing free mixing with general community.
Exclusion
- Bedridden subjects
- Previous vaccination against influenza since February 2008.
- Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any contra-indication to intramuscular administration of the influenza vaccines.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
- Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F).
Key Trial Info
Start Date :
September 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2011
Estimated Enrollment :
43695 Patients enrolled
Trial Details
Trial ID
NCT00753272
Start Date
September 15 2008
End Date
January 5 2011
Last Update
June 8 2018
Active Locations (274)
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1
GSK Investigational Site
Alabaster, Alabama, United States, 35007
2
GSK Investigational Site
Huntsville, Alabama, United States, 35802
3
GSK Investigational Site
Mobile, Alabama, United States, 36608
4
GSK Investigational Site
Chandler, Arizona, United States, 85224