Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
- Conditions
- Influenza
- Interventions
- Biological: FluzoneBiological: FlumistOther: Physiologic saline
- Registration Number
- NCT00538512
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1952
- Healthy adult men and women
- Age 18-49 years
- Who reside geographically close to one of the four study sites in Michigan
- Persons with any of the health conditions for which the inactivated vaccine is recommended
- Persons for whom either vaccine is contraindicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TIV Fluzone the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur LAIV Flumist live-attenuated influenza vaccine Flumist, manufactured by MedImmune Placebo Physiologic saline Physiologic saline administered as a nasal spray or intramuscular injection
- Primary Outcome Measures
Name Time Method Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza one influenza season - 2007-2008
- Secondary Outcome Measures
Name Time Method Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection Time between prevaccination visit and postvaccination visit; typically about 30 days. 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.
Immune Response to Vaccination and Infection Postvaccination to postseason visit; typically about 3 months. 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.
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. Time between prevaccination and postvaccination, typically about 30 days. 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).
Trial Locations
- Locations (4)
University of Michigan School of Public Heatlh
🇺🇸Ann Arbor, Michigan, United States
Eastern Michigan University Health Services
🇺🇸Ypsilanti, Michigan, United States
Western Michigan University Health Services
🇺🇸Kalamazoo, Michigan, United States
Central Michigan University Health Services
🇺🇸Mount Pleasant, Michigan, United States