CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,952 enrolled
Drug / intervention
Fluzone +2 morebiological
Likely dose
Single dose Fluzone (trivalent inactivated) or Flumist (live-attenuated) or physiologic saline placeboAI-extracted
Key inclusion· 3
  • ✓Healthy adult men and women
  • ✓Age 18-49 years
  • ✓Reside geographically close to one of the four study sites in Michigan
Key exclusion· 2
  • ✕Any health conditions for which the inactivated vaccine is recommended
  • ✕Persons for whom either vaccine is contraindicated

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00538512
NCT00538512Phase 4Completed
CompareCT.gov

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

University of Michigan·interventional·Posted Oct 2, 2007·Updated Dec 6, 2017

In Brief

A Phase 4 clinical trial evaluating Fluzone, Flumist, and 1 other intervention for Influenza. Completed, enrolled 1,952 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsSanofi Pasteur, a Sanofi Company

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2007
Enrollment StartSep 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.8 years ago

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