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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza virus vaccine (Fluviral)
* Biological: Saline placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza virus vaccine (Fluviral)|nan|
|Biological: Saline placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine, efficacy, safety, immunogenicity