CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
High dose influenza vaccine Sanofi-Pasteur +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/NCT01189123
NCT01189123N/ACompleted

Evaluation of Cell-mediated Immunity and Antibody Response to Influenza Vaccination and Correlates of Protection in Seniors

Vanderbilt University·interventional·Posted Aug 26, 2010·Updated Apr 24, 2014

In Brief

A clinical study evaluating High dose influenza vaccine Sanofi-Pasteur and fluzone by sanofi pasteur for Immunity to Influenza Vaccine. Completed, enrolled 105 participants across 1 site.

Detailed Summary

This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. The investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease Control and Prevention on this study. There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. Patients will be randomized to receive either the standard dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.8 years ago

Interventions

High dose influenza vaccine Sanofi-Pasteurbiological

High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection

fluzone by sanofi pasteurbiological

standard dose fluzone