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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


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


Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.


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


- 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

Page last updated: August 20, 2015

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