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

19. januar 2007 opdateret af: ID Biomedical Corporation, Quebec

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Influenza

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

900

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Florida
  - Pembroke Pines, Florida, Forenede Stater, 33024
    - University Clinical Research, Inc.
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30342
    - Radiant Research
- Illinois
  - Chicago, Illinois, Forenede Stater, 60610
    - Radiant Research
- Kansas
  - Overland Park, Kansas, Forenede Stater, 66211
    - Vince and Associates Clinical Research
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64114
    - The Center for Pharmaceutical Research
- New York
  - Endwell, New York, Forenede Stater, 13760
    - Regional Clinical Research
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester Medical Center
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45236
    - Radiant Research
- Rhode Island
  - Warwick, Rhode Island, Forenede Stater, 02886
    - Omega Medical Research
- Virginia
  - Fairfax, Virginia, Forenede Stater, 22030
    - Pi-Coor Clinical Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Uddannelse/Rådgivning/Træning
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.

Sekundære resultatmål

Resultatmål
Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ID Biomedical Corporation, Quebec

Efterforskere

Studieleder: Nancy Bouveret, MD, ID Biomedical of Quebec

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Studieafslutning

1. februar 2006

Datoer for studieregistrering

Først indsendt

3. oktober 2005

Først indsendt, der opfyldte QC-kriterier