Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults

NCT01389479

Influenza

COMPLETED PHASE3

Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.

NCT00216242

Influenza

UNKNOWN PHASE3

Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

NCT00197288

Influenza

COMPLETED PHASE3

Immunogenicity of Influenza Vaccinations

NCT06518577

Influenza

COMPLETED PHASE4

Trial to Describe the Safety and Immunogenicity of Fluzone®

NCT00524940

Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Influenza virus vaccine (Fluviral)

Intervention Type BIOLOGICAL

Influenza virus vaccine (Fluzone)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes