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

Sponsored by:	ID Biomedical Corporation, Quebec
Information provided by:	ID Biomedical Corporation, Quebec
ClinicalTrials.gov Identifier:	NCT00216242

Purpose

The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.

Condition	Intervention	Phase
Influenza	Biological: Influenza virus vaccine (Fluviral) Biological: Saline placebo	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Sodium chloride Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age

Further study details as provided by ID Biomedical Corporation, Quebec:

Primary Outcome Measures:

Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.

Secondary Outcome Measures:

Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
Rate of other adverse events through approximately 135 days post-treatment;
Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
Geometric mean influenza-specific antibody titers at 21 days after treatment.

Estimated Enrollment:	7400
Study Start Date:	September 2005
Estimated Study Completion Date:	May 2007

Detailed Description:

Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Good health by history and physical exam
Reliable access to a telephone
Study comprehension and informed consent

Exclusion Criteria:

Systolic BP >/= 140; diastolic BP >/= 90
Uncontrolled medical or psychiatric illness (change in last 3 months)
Cancer, or treatment for cancer within 3 years
Cardio-pulmonary disease requiring chronic treatment
Insulin dependent diabetes mellitus
Renal dysfunction (creatinine >/= 1.7 mg/dL)
Hemoglobinopathies
Clotting disorders that increase the risk of IM injections
Immunosuppressive illnesses or drugs
History of demyelinating disease (esp. Guillian-Barre syndrome)
Employment in professions at high risk for influenza transmission
Household contact with high-risk individuals
Receipt of:

a) Immunosuppressive drugs i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
History of:
1. Severe reactions to other influenza vaccines
2. Allergy to egg proteins
3. Sensitivity to mercurials
Pregnancy/ high risk of pregnancy
1. Positive urine pregnancy test before treatment
2. Women of child-bearing potential without credible contraceptive plan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216242

Show 44 Study Locations

Sponsors and Collaborators

ID Biomedical Corporation, Quebec

Investigators

Study Director:

Nancy Bouveret, MD

ID Biomedical of Quebec

More Information

Study ID Numbers:	IDB707-106
Study First Received:	September 20, 2005
Last Updated:	December 8, 2006
ClinicalTrials.gov Identifier:	NCT00216242
Health Authority:	United States: Food and Drug Administration

Keywords provided by ID Biomedical Corporation, Quebec:

influenza
vaccine
efficacy
safety
immunogenicity

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009