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

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Fluzone Biological: Flumist Other: Physiologic saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza [ Time Frame: one influenza season - 2007-2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection [ Time Frame: one influenza season - 2007-08 ] [ Designated as safety issue: No ]

Enrollment:	1952
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: TIV the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur	Biological: Fluzone single dose licensed trivalent inactivated influenza vaccine (2007-08)
Active Comparator: LAIV live-attenuated influenza vaccine Flumist, manufactured by MedImmune	Biological: Flumist single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
Placebo Comparator: Placebo 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
Persons for whom either vaccine is contraindicated

Contacts and Locations

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

Locations

United States, Michigan
University of Michigan School of Public Heatlh
Ann Arbor, Michigan, United States, 48109
Western Michigan University Health Services
Kalamazoo, Michigan, United States, 49008
Central Michigan University Health Services
Mt. Pleasant, Michigan, United States, 48859
Eastern Michigan University Health Services
Ypsilanti, Michigan, United States, 48197

Sponsors and Collaborators

University of Michigan

Sanofi Pasteur MSD

Investigators

Principal Investigator:

Arnold S. Monto, MD

University of Michigan School of Public Health

More Information

Publications:

Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009 Sep 24;361(13):1260-7.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011 Dec 15;204(12):1879-85. Epub 2011 Oct 12.

Petrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011 May 1;203(9):1309-15. Epub 2011 Mar 4.

Responsible Party:	Arnold S. Monto, University of Michigan School of Public Health
ClinicalTrials.gov Identifier:	NCT00538512 History of Changes
Other Study ID Numbers:	FLUVACS
Study First Received:	October 1, 2007
Results First Received:	August 8, 2011
Last Updated:	August 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Influenza
Live attenuated influenza vaccine
Inactivated influenza vaccine
Vaccine Efficacy

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013