Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Fluzone (Biological); Flumist (Biological); Physiologic saline (Other)
Phase: Phase 4
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Arnold S. Monto, MD, Principal Investigator, Affiliation: University of Michigan School of Public Health
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.
Clinical Details
Official title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
Secondary outcome: Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Michigan School of Public Heatlh, Ann Arbor, Michigan 48109, United States
Western Michigan University Health Services, Kalamazoo, Michigan 49008, United States
Central Michigan University Health Services, Mt. Pleasant, Michigan 48859, United States
Eastern Michigan University Health Services, Ypsilanti, Michigan 48197, United States
Additional Information
Related publications: Ohmit SE, Victor JC, Rotthoff JR, Teich ER, Truscon RK, Baum LL, Rangarajan B, Newton DW, Boulton ML, Monto AS. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006 Dec 14;355(24):2513-22.
Starting date: September 2007
Last updated: August 8, 2011
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