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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Flumist; Biological: Fluzone; Other: Physiologic saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00538512

FLUVACS

Details and patient eligibility

About

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.

Enrollment: 1,952 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1,952 participants in 3 patient groups, including a placebo group

TIV

Active Comparator group

Description:

the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur

Treatment:

Biological: Fluzone

LAIV

Active Comparator group

Description:

live-attenuated influenza vaccine Flumist, manufactured by MedImmune

Treatment:

Biological: Flumist

Placebo

Placebo Comparator group

Description:

Physiologic saline administered as a nasal spray or intramuscular injection

Treatment:

Other: Physiologic saline