Comparative Study of Influenza Vaccines in Adults, FLUVACS-Year 4 - Full Text View

Sponsors and Collaborators:	University of Michigan sanofi pasteur
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00538512

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Fluzone Biological: Flumist Other: Physiologic saline	Phase IV

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Comparative Study of Influenza Vaccines in Adults, FLUVACS-Year 4

Further study details as provided by University of Michigan:

Primary Outcome Measures:

laboratory-confirmed (culture, PCR, serology) symptomatic influenza [ Time Frame: one influenza season - 2007-2008 ]

Secondary Outcome Measures:

measure immune response induced by the vaccines and identify serologic correlates of immune protection [ Time Frame: one influenza season - 2007-08 ]

Estimated Enrollment:	1980
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
TIV: Active Comparator the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur	Biological: Fluzone single dose licensed trivalent inactivated influenza vaccine (2007-08)
LAIV: Active Comparator live-attenuated influenza vaccine Flumist, manufactured by MedImmune	Biological: Flumist single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
Placebo: Placebo Comparator Physiologic saline administered as a nasal spray or intramuscular injection	Other: Physiologic saline single dose placebo administered as an intranasal spray or intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 and persons for whom either vaccine is contraindicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538512

Contacts

Contact: Arnold S. Monto, MD	734-764-5453	asmonto@umich.edu
Contact: Suzanne E. Ohmit, DrPH	734-763-6422	sohmit@umich.edu

Locations

United States, Michigan
University of Michigan School of Public Heatlh	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Arnold S Monto, MD
Sub-Investigator: Suzanne E. Ohmit, DrPH
Central Michigan University Health Services	Recruiting
Mt. Pleasant, Michigan, United States, 48859
Principal Investigator: Arnold S Monto, MD
Eastern Michigan University Health Services	Recruiting
Ypsilanti, Michigan, United States, 48197
Principal Investigator: Arnold S Monto, MD
Western Michigan University Health Services	Recruiting
Kalamazoo, Michigan, United States, 49008
Principal Investigator: Arnold S Monto, MD

Sponsors and Collaborators

University of Michigan

sanofi pasteur

Investigators

Principal Investigator:

Arnold S. Monto, MD

University of Michigan School of Public Health

More Information

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.

Study ID Numbers:	FLUVACS
Study First Received:	October 1, 2007
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00538512
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Influenza
Live attenuated influenza vaccine
Inactivated influenza vaccine
Vaccine Efficacy

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009