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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538512
First Posted: October 2, 2007
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Arnold S. Monto, University of Michigan
October 1, 2007
October 2, 2007
August 8, 2011
September 12, 2011
December 6, 2017
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 ]
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: Time between prevaccination visit and postvaccination visit; typically about 30 days. ]
    Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.
  • Immune Response to Vaccination and Infection [ Time Frame: Postvaccination to postseason visit; typically about 3 months. ]
    Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.
  • Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. [ Time Frame: Time between prevaccination and postvaccination, typically about 30 days. ]
    Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).
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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00538512
FLUVACS
No
Not Provided
Not Provided
Arnold S. Monto, University of Michigan
University of Michigan
Sanofi Pasteur, a Sanofi Company
Principal Investigator: Arnold S. Monto, MD University of Michigan School of Public Health
University of Michigan
November 2017

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