CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,957 enrolled
Drug / intervention
HD Fluzone Vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01720277
NCT01720277Phase 4Completed
CompareCT.gov

High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation

Insight Therapeutics, LLC·interventional·Posted Nov 2, 2012·Updated May 23, 2018

In Brief

A Phase 4 clinical trial evaluating HD Fluzone Vaccine and SD Fluzone Vaccine for Influenza. Completed, enrolled 2,957 participants across 2 sites.

Detailed Summary

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsBrown University

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2013
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.7 years ago

Interventions

HD Fluzone Vaccinebiological

Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).

SD Fluzone Vaccinebiological

Nursing home residents are allocated to receive standard trivalent vaccine (TIV).