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

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Influenza virus vaccine (Fluviral)
Saline placebo
Sponsored by
ID Biomedical Corporation, Quebec
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Influenza focused on measuring influenza, vaccine, efficacy, safety, immunogenicity

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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: Severe reactions to other influenza vaccines Allergy to egg proteins Sensitivity to mercurials Pregnancy/ high risk of pregnancy Positive urine pregnancy test before treatment Women of child-bearing potential without credible contraceptive plan

Sites / Locations

  • Benchmark Research
  • Benchmark Research
  • Radiant Research
  • Longmont Med. Research Center
  • Miami Research Associates
  • University Clinical Research Associates
  • Emory University
  • Radiant Research
  • Dwight D. Eisenhower Army Medical Center
  • Advanced Clinical Research
  • Radiant Research
  • Radiant Research
  • Preventive Intervention Center
  • Johnson County ClinTrials
  • Kentucky Pediatric/Adult Research
  • Rockville Internal Medicine Group
  • Meridian Clinical Research
  • Anderson and Collins Clinical Research
  • Regional Clinical Research
  • Wake Research Associates
  • National Carolina Children and Adult Clinical Research Foundation
  • Carolina medical Trials
  • Radiant Research
  • Brandywine Clinical Research
  • Omega Clinical Trials
  • Radiant Research
  • Spartanburg Medical Research
  • Clinical Research Associates
  • Benchmark Research
  • Benchmark Research
  • Covance
  • Allergy and Asthma Research Associates
  • Research Across America
  • Benchmark Research
  • Killeen Scott and White Regional Clinic
  • Research Across America
  • Benchmark Research
  • J. Lewis Research, Inc.
  • J. Lewis Research, Inc.
  • J. Lewis Research
  • PI-Coor Clinical Research, LLC
  • Clinical Research Associates of Tidewater
  • Center for Health Studies

Outcomes

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.

Full Information

First Posted
September 20, 2005
Last Updated
December 8, 2006
Sponsor
ID Biomedical Corporation, Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT00216242
Brief Title
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

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ID Biomedical Corporation, Quebec

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, vaccine, efficacy, safety, immunogenicity

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
7400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (Fluviral)
Intervention Type
Biological
Intervention Name(s)
Saline placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
Title
Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
Title
Rate of other adverse events through approximately 135 days post-treatment;
Title
Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
Title
Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
Title
Geometric mean influenza-specific antibody titers at 21 days after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Severe reactions to other influenza vaccines Allergy to egg proteins Sensitivity to mercurials Pregnancy/ high risk of pregnancy Positive urine pregnancy test before treatment Women of child-bearing potential without credible contraceptive plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Bouveret, MD
Organizational Affiliation
ID Biomedical of Quebec
Official's Role
Study Director
Facility Information:
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Benchmark Research
City
San Fransisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Radiant Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Longmont Med. Research Center
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
University Clinical Research Associates
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Dwight D. Eisenhower Army Medical Center
City
Ft. Gordon
State/Province
Georgia
ZIP/Postal Code
30905-5650
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Radiant Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Preventive Intervention Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Johnson County ClinTrials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Rockville Internal Medicine Group
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Anderson and Collins Clinical Research
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
Regional Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
National Carolina Children and Adult Clinical Research Foundation
City
Sylva
State/Province
North Carolina
ZIP/Postal Code
28779
Country
United States
Facility Name
Carolina medical Trials
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
Omega Clinical Trials
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Radiant Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29611
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Clinical Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78728
Country
United States
Facility Name
Covance
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Allergy and Asthma Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Killeen Scott and White Regional Clinic
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
16904
Country
United States
Facility Name
J. Lewis Research, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84084
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Center for Health Studies
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20236548
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.
Results Reference
derived

Learn more about this trial

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

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