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

University of Michigan1,952 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,952

Conditions

Influenza

Interventions

FluzoneBIOLOGICAL

single dose licensed trivalent inactivated influenza vaccine (2007-08)

FlumistBIOLOGICAL

single dose licensed live-attenuated influenza vaccine Flumist (2007-08)

Physiologic salineOTHER

single dose placebo administered as an intranasal spray or intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

University of Michigan School of Public Heatlh

Ann Arbor, Michigan, United States

Western Michigan University Health Services

Kalamazoo, Michigan, United States

Central Michigan University Health Services

Mount Pleasant, Michigan, United States

Eastern Michigan University Health Services

Ypsilanti, Michigan, United States

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

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 frame: Time between prevaccination visit and postvaccination visit; typically about 30 days.

Immune Response to Vaccination and Infection

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.

Time frame: Postvaccination to postseason visit; typically about 3 months.

Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.

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 frame: Time between prevaccination and postvaccination, typically about 30 days.

Data from ClinicalTrials.gov

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