Clinical trial NCT00216242: Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Influenza
Keywords: influenza
vaccine
efficacy
safety
immunogenicity
Lead sponsor: ID Biomedical Corporation, Quebec
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 7400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

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

Primary outcomes:
measure: Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
Secondary outcomes:
measure: Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
measure: Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
measure: Rate of other adverse events through approximately 135 days post-treatment;
measure: Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
measure: Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
measure: Geometric mean influenza-specific antibody titers at 21 days after treatment.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Fransisco
country: United States
facility: Benchmark Research
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Longmont
country: United States
facility: Longmont Med. Research Center
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Associates
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Ft. Gordon
country: United States
facility: Dwight D. Eisenhower Army Medical Center
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Boise
country: United States
facility: Radiant Research
state: Idaho
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Iowa City
country: United States
facility: Preventive Intervention Center
state: Iowa
city: Lenexa
country: United States
facility: Johnson County ClinTrials
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Rockville
country: United States
facility: Rockville Internal Medicine Group
state: Maryland
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Edison
country: United States
facility: Anderson and Collins Clinical Research
state: New Jersey
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Sylva
country: United States
facility: National Carolina Children and Adult Clinical Research Foundation
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina medical Trials
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Clinical Trials
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Covance
state: Texas
city: Dallas
country: United States
facility: Allergy and Asthma Research Associates
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Killeen
country: United States
facility: Killeen Scott and White Regional Clinic
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: West Jordan
country: United States
facility: J. Lewis Research
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Center for Health Studies
state: Washington
Study officials:
affiliation: ID Biomedical of Quebec
name: Nancy Bouveret, MD
role: STUDY_DIRECTOR
References:
citation: 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.