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

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00538512
First received: October 1, 2007
Last updated: August 8, 2011
Last verified: February 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 22, 2014