Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

Completed · Phase 3

Conditions studied: Influenza

In brief

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 phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

Key facts

Study ID

NCT00753272

Run by

GlaxoSmithKline

People needed

43695

Starts

2008-09-15

Expected to finish

2011-01-05

Last updated by the study team

2018-06-08

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• GSK Investigational Site — Delray Beach, Florida, United States
• GSK Investigational Site — Inverness, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Boise, Idaho, United States
• GSK Investigational Site — Peoria, Illinois, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Hackensack, New Jersey, United States
• GSK Investigational Site — Somers Point, New Jersey, United States
• GSK Investigational Site — Camillus, New York, United States
• GSK Investigational Site — Endwell, New York, United States
• GSK Investigational Site — Johnson City, New York, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Cary, North Carolina, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Crystal River, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.