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

University of Michigan4 sites in 1 country1,952 target enrollmentSeptember 2007

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: University of Michigan
Enrollment: 1952
Locations: 4
Primary Endpoint: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

May 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Arnold S. Monto

Principal Investigator

University of Michigan

Eligibility 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

Outcomes

Primary Outcomes

Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza

Time Frame: one influenza season - 2007-2008

Secondary Outcomes

Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection(Time between prevaccination visit and postvaccination visit; typically about 30 days.)
Immune Response to Vaccination and Infection(Postvaccination to postseason visit; typically about 3 months.)
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.(Time between prevaccination and postvaccination, typically about 30 days.)