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

NCT ID: NCT00216242

Last Updated: 2006-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 7400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-05-31

Brief 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.

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.

Conditions

Influenza

Keywords

influenza; vaccine; efficacy; safety; immunogenicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: DOUBLE

Interventions

Influenza virus vaccine (Fluviral)

Intervention Type: BIOLOGICAL

Saline placebo

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ID Biomedical Corporation, Quebec

INDUSTRY

Sponsor Role: lead

Principal Investigators

Nancy Bouveret, MD

Role: STUDY_DIRECTOR

ID Biomedical of Quebec

Locations

Benchmark Research

Sacramento, California, United States

Benchmark Research

San Francisco, California, United States

Radiant Research

Denver, Colorado, United States

Longmont Med. Research Center

Longmont, Colorado, United States

Miami Research Associates

Miami, Florida, United States

University Clinical Research Associates

Pembroke Pines, Florida, United States

Emory University

Atlanta, Georgia, United States

Radiant Research

Atlanta, Georgia, United States

Dwight D. Eisenhower Army Medical Center

Fort Eisenhower, Georgia, United States

Advanced Clinical Research

Boise, Idaho, United States

Radiant Research

Boise, Idaho, United States

Radiant Research

Chicago, Illinois, United States

Preventive Intervention Center

Iowa City, Iowa, United States

Johnson County ClinTrials

Lenexa, Kansas, United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Rockville Internal Medicine Group

Rockville, Maryland, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Anderson and Collins Clinical Research

Edison, New Jersey, United States

Regional Clinical Research

Endwell, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

National Carolina Children and Adult Clinical Research Foundation

Sylva, North Carolina, United States

Carolina medical Trials

Winston-Salem, North Carolina, United States

Radiant Research

Cincinnati, Ohio, United States

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

Omega Clinical Trials

Warwick, Rhode Island, United States

Radiant Research

Anderson, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Clinical Research Associates

Nashville, Tennessee, United States

Benchmark Research

Austin, Texas, United States

Benchmark Research

Austin, Texas, United States

Covance

Austin, Texas, United States

Allergy and Asthma Research Associates

Dallas, Texas, United States

Research Across America

Dallas, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Killeen Scott and White Regional Clinic

Killeen, Texas, United States

Research Across America

Plano, Texas, United States

Benchmark Research

San Angelo, Texas, United States

J. Lewis Research, Inc.

Salt Lake City, Utah, United States

J. Lewis Research, Inc.

Salt Lake City, Utah, United States

J. Lewis Research

West Jordan, Utah, United States

PI-Coor Clinical Research, LLC

Burke, Virginia, United States

Clinical Research Associates of Tidewater

Norfolk, Virginia, United States

Center for Health Studies

Seattle, Washington, United States

Countries

United States

References

Jackson LA, Gaglani MJ, Keyserling HL, Balser J, Bouveret N, Fries L, Treanor JJ. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010 Mar 17;10:71. doi: 10.1186/1471-2334-10-71.

Reference Type: DERIVED

PMID: 20236548 (View on PubMed)

Other Identifiers

IDB707-106

Identifier Type: -

Identifier Source: org_study_id