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

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.
 
ClinicalTrials.gov Identifier: NCT00538512
Recruitment Status : Completed
First Posted : October 2, 2007
Results First Posted : September 12, 2011
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Arnold S. Monto, University of Michigan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: Fluzone Biological: Flumist Other: Physiologic saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1952 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Study Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza [ Time Frame: one influenza season - 2007-2008 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538512


Locations
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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
Mount Pleasant, Michigan, United States, 48859
Eastern Michigan University Health Services
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Arnold S. Monto, MD University of Michigan School of Public Health
More Information
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Publications of Results:

Other Publications:

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

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Responsible Party: Arnold S. Monto, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00538512    
Other Study ID Numbers: FLUVACS
First Posted: October 2, 2007    Key Record Dates
Results First Posted: September 12, 2011
Last Update Posted: December 6, 2017
Last Verified: November 2017
Keywords provided by Arnold S. Monto, University of Michigan:
Influenza
Live attenuated influenza vaccine
Inactivated influenza vaccine
Vaccine Efficacy
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases