CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 205 enrolled
Drug / intervention
High Dose Inactivated Influenza Vaccine +1 morebiological
Likely dose
High Dose Inactivated Influenza Vaccine 0.5 mlfrom 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/NCT01654224
NCT01654224Phase 4Completed
CompareCT.gov

Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

University of Pittsburgh·interventional·Posted Jul 31, 2012·Updated Jul 2, 2017

In Brief

A Phase 4 clinical trial evaluating High Dose Inactivated Influenza Vaccine and Standard Dose Inactivated Influenza Vaccine for Influenza. Completed, enrolled 205 participants across 1 site.

Detailed Summary

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 31, 2012
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.9 years ago

Interventions

High Dose Inactivated Influenza Vaccinebiological

0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin

Standard Dose Inactivated Influenza Vaccinebiological

0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin