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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00216242
• Other study ID #: IDB707-106
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: December 8, 2006
• Start date: September 2005
• Est. completion date: May 2007

Study information

• Verified date: December 2006
• Source: ID Biomedical Corporation, Quebec
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7400
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza virus vaccine (Fluviral)

• Saline placebo

Locations

Country	Name	City	State
United States	Radiant Research	Anderson	South Carolina
United States	Emory University	Atlanta	Georgia
United States	Radiant Research	Atlanta	Georgia
United States	Benchmark Research	Austin	Texas
United States	Benchmark Research	Austin	Texas
United States	Covance	Austin	Texas
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Advanced Clinical Research	Boise	Idaho
United States	Radiant Research	Boise	Idaho
United States	PI-Coor Clinical Research, LLC	Burke	Virginia
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	Allergy and Asthma Research Associates	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Radiant Research	Denver	Colorado
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Anderson and Collins Clinical Research	Edison	New Jersey
United States	Regional Clinical Research	Endwell	New York
United States	Benchmark Research	Fort Worth	Texas
United States	Dwight D. Eisenhower Army Medical Center	Ft. Gordon	Georgia
United States	Preventive Intervention Center	Iowa City	Iowa
United States	Killeen Scott and White Regional Clinic	Killeen	Texas
United States	Johnson County ClinTrials	Lenexa	Kansas
United States	Longmont Med. Research Center	Longmont	Colorado
United States	Miami Research Associates	Miami	Florida
United States	Clinical Research Associates	Nashville	Tennessee
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Meridian Clinical Research	Omaha	Nebraska
United States	University Clinical Research Associates	Pembroke Pines	Florida
United States	Research Across America	Plano	Texas
United States	Wake Research Associates	Raleigh	North Carolina
United States	Rockville Internal Medicine Group	Rockville	Maryland
United States	Benchmark Research	Sacramento	California
United States	J. Lewis Research, Inc.	Salt Lake City	Utah
United States	J. Lewis Research, Inc.	Salt Lake City	Utah
United States	Benchmark Research	San Angelo	Texas
United States	Benchmark Research	San Fransisco	California
United States	Center for Health Studies	Seattle	Washington
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	National Carolina Children and Adult Clinical Research Foundation	Sylva	North Carolina
United States	Omega Clinical Trials	Warwick	Rhode Island
United States	J. Lewis Research	West Jordan	Utah
United States	Carolina medical Trials	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ID Biomedical Corporation, Quebec

Country where clinical trial is conducted

United States, 

Outcome

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