Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.

Official Title
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Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluzone
* Biological: Flumist
* Other: Physiologic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult men and women Age 18-49 years Who reside geographically close to one of the four study sites in Michigan Exclusion Criteria: Persons with any of the health conditions for which the inactivated vaccine is recommended Persons for whom either vaccine is contraindicated

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIV<br>the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur | Biological: Fluzone<br>* single dose licensed trivalent inactivated influenza vaccine (2007-08)<br>|
| Active Comparator: LAIV<br>live-attenuated influenza vaccine Flumist, manufactured by MedImmune | Biological: Flumist<br>* single dose licensed live-attenuated influenza vaccine Flumist (2007-08)<br>|
| Placebo Comparator: Placebo<br>Physiologic saline administered as a nasal spray or intramuscular injection | Other: Physiologic saline<br>* single dose placebo administered as an intranasal spray or intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza |  | one influenza season - 2007-2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection | Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit. | Time between prevaccination visit and postvaccination visit; typically about 30 days. | 
| Immune Response to Vaccination and Infection | Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit. | Postvaccination to postseason visit; typically about 3 months. | 
| Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. | Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection). | Time between prevaccination and postvaccination, typically about 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Live attenuated influenza vaccine, Inactivated influenza vaccine, Vaccine Efficacy