Status:
COMPLETED
Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months ...
Detailed Description
* Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately: * Study vaccine: full dose of Fluarix by IM administration. * Co...
Eligibility Criteria
Inclusion
- All adults 18 years and older.
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions .
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- 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(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
- Acute disease at the time of enrollment. (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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F)).
- History of Guillain Barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine.
- Pregnancy and lactating females.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
1847 Patients enrolled
Trial Details
Trial ID
NCT00197288
Start Date
October 1 2005
End Date
June 1 2006
Last Update
January 18 2017
Active Locations (15)
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1
GSK Investigational Site
Clearwater, Florida, United States, 33761
2
GSK Investigational Site
Evansville, Indiana, United States, 47714
3
GSK Investigational Site
Baltimore, Maryland, United States, 21201
4
GSK Investigational Site
St Louis, Missouri, United States, 63110