CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine +2 morebiological
Likely dose
Fluzone Quadrivalent vaccine 0.25 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/NCT03308825
NCT03308825Phase 4Completed

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2017-2018 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 13, 2017·Updated Mar 29, 2022

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine and Fluzone High-Dose vaccine for Influenza and Flu. Completed, enrolled 240 participants across 3 sites.

Detailed Summary

The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 13, 2017
Enrollment StartSep 11, 2017
Primary CompletionNov 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.7 years ago

Interventions

Fluzone Quadrivalent vaccinebiological

0.25 mL, Intramuscular

Fluzone Quadrivalent vaccinebiological

0.5 mL, Intramuscular

Fluzone High-Dose vaccinebiological

0.5 mL, Intramuscular