Status:
COMPLETED
Fluarix Immunogenicity and Safety Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4 centers will rece...
Detailed Description
This study is a randomized, double-blinded, placebo controlled Phase III study to evaluate the immunogenicity and the safety of GSK Bio influenza vaccine (Fluarix) administered intramuscularly in heal...
Eligibility Criteria
Inclusion
- A male or female age between18-64 years at the time of the vaccination.
- 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.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestogen-only implantable, cutaneous hormonal patch or injectable contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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.
- 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. (For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day.)
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the 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 including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate.
- Previous vaccination against influenza (2004-2005 influenza vaccine) within the 9 months prior to enrollment.
- 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)).
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders, including history of Guillain Barré syndrome
- History of seizures, with the exception of a single febrile seizure during childhood.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of enrollment in this study.
- Has an underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS.
- 18 years of age and on chronic aspirin therapy
- Residents of nursing homes and long term care facilities.
- Health care workers involved in direct patient care.
- Out-of-home caregivers and household contacts of children \<6 months.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT00100399
Start Date
December 1 2004
End Date
December 1 2004
Last Update
August 27 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
2
University of Rochester
Rochester, New York, United States, 14642
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
4
Baylor College of Medicine
Houston, Texas, United States, 77030