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

NCT00538512 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1952

Last updated 2017-12-06

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Fluzone

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

BIOLOGICAL

Flumist

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

OTHER

Physiologic saline

single dose placebo administered as an intranasal spray or intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Arnold S. Monto, MD · University of Michigan School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538512 on ClinicalTrials.gov