CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation +1 morebiological
Likely dose
Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation 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/NCT01430819
NCT01430819Phase 4Completed
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Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 8, 2011·Updated May 27, 2013

In Brief

A Phase 4 clinical trial evaluating Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation for Influenza. Completed, enrolled 300 participants across 6 sites.

Detailed Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.8 years ago

Interventions

Influenza Virus Vaccine: Fluzone® 2011-2012 Formulationbiological

0.5 mL, Intramuscular

Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulationbiological

0.5 mL, Intramuscular