Clinical trial NCT00232947: Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Official title: A Non-Inferiority Comparison of Fluviral™ Influenza Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: vaccine
elderly
immunogenicity
safety
Lead sponsor: ID Biomedical Corporation, Quebec
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 900
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.

Detailed description: Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.

Eligibility criteria: Inclusion Criteria:

* Stable health status
* Access to a consistent means of telephone contact.
* Comprehension of study requirements, availability for study duration
* Availability and ability to attend scheduled visits
* Females post menopausal, sterile or using accepted contraceptive measures
* Competence to provide informed consent

Exclusion Criteria:

* Presence of significant acute or chronic medical or neuropsych. illness
* New medical or surgical treatment w/i 1 month
* Change in medication dose due to uncontrolled symptoms w/i 1 month
* Hospitalization w/i 1 month
* Any unusual risk (for age group) of serious adverse events w/i 1 month
* Any neuropsychiatric condition altering competence for consent
* Any neuropsychiatric condition preventing accurate safety reports
* Febrile illness on day of treatment
* Employment in professions at high risk of influenza transmission
* Residence in a long-term-care facility or with an immunocompromised person
* Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100
* Cancer w/i 3 years
* Immunosuppressive of immunodeficient conditions
* Treatment with systemic glucocorticoids \> replacement
* Treatment with cytotoxic or immunosuppressant drugs
* Treatment with immune globulins
* Clotting disorders that increase the risks of intramuscular injections
* History of demyelinating disease or GBS
* Pregnancy or nursing
* Absence of contraceptive practices in women with childbearing potential
* Planned administration of non-influenza vaccines within 30 days
* Receipt of any investigational drug within 30 days
* Receipt of immune globulin treatment within 3 months
* Known or suspected allergy to egg proteins, gelatin, or thimerosal
* History of severe adverse reactions toflu vaccines
* Prior receipt of 2005-6 influenza vaccine

Primary outcomes:
measure: Rate of signficant rises in serum antibody titers against viruses in the vaccines.
measure: Geometric mean serum antibody titers on day 21.
Secondary outcomes:
measure: Rates of specific, solicited vaccine reactogenicicty complaints.
measure: Rates of adverse events.
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Fairfax
country: United States
facility: PI-Coor Clinical Research
state: Virginia
Study officials:
affiliation: ID Biomedical of Quebec
name: Nancy Bouveret, MD
role: STUDY_DIRECTOR
References: