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

October 1, 2007
August 8, 2011
September 2007
May 2008   (final data collection date for primary outcome measure)
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza [ Time Frame: one influenza season - 2007-2008 ] [ Designated as safety issue: No ]
laboratory-confirmed (culture, PCR, serology) symptomatic influenza [ Time Frame: one influenza season - 2007-2008 ]
Complete list of historical versions of study NCT00538512 on ClinicalTrials.gov Archive Site
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 ]
measure immune response induced by the vaccines and identify serologic correlates of immune protection [ Time Frame: one influenza season - 2007-08 ]
Not Provided
Not Provided
 
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Fluzone
    single dose licensed trivalent inactivated influenza vaccine (2007-08)
  • Biological: Flumist
    single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
  • Other: Physiologic saline
    single dose placebo administered as an intranasal spray or intramuscular injection
  • Active Comparator: TIV
    the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
    Intervention: Biological: Fluzone
  • Active Comparator: LAIV
    live-attenuated influenza vaccine Flumist, manufactured by MedImmune
    Intervention: Biological: Flumist
  • Placebo Comparator: Placebo
    Physiologic saline administered as a nasal spray or intramuscular injection
    Intervention: Other: Physiologic saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1952
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00538512
FLUVACS
No
Arnold S. Monto, University of Michigan School of Public Health
University of Michigan
Sanofi Pasteur MSD
Principal Investigator: Arnold S. Monto, MD University of Michigan School of Public Health
University of Michigan
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP