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

November 1, 2017 updated by: Arnold S. Monto, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1952

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
Time Frame: one influenza season - 2007-2008
one influenza season - 2007-2008

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time between prevaccination visit and postvaccination visit; typically about 30 days.
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.
Postvaccination to postseason visit; typically about 3 months.
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).
Time between prevaccination and postvaccination, typically about 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

  • Principal Investigator: Arnold S. Monto, MD, University of Michigan School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (ESTIMATE)

October 2, 2007

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUVACS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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