Influenza Clinical Trial
Official title:
A Phase III, Observer-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix™ (GlaxoSmithKline Biologicals) Compared With Fluzone® (Aventis Pasteur) Administered Intramuscularly in Adults 18 Years and Older in the U.S.
Verified date | January 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 after vaccination.
Status | Completed |
Enrollment | 1847 |
Est. completion date | June 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Buffalo | New York |
United States | GSK Investigational Site | Carnegie | Pennsylvania |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Clearwater | Florida |
United States | GSK Investigational Site | Erie | Pennsylvania |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Katy | Texas |
United States | GSK Investigational Site | Marshfield | Wisconsin |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Poughkeepsie | New York |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | Warwick | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs) | |||
Secondary | Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs) | |||
Secondary | Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age | |||
Secondary | Safety comparison (sol local, general & unsol AEs, SAEs) |
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