CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 240 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine, 2018-2019 formulation +2 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/NCT03617523
NCT03617523Phase 4Completed

Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 6, 2018·Updated Mar 29, 2022

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, 2018-2019 formulation, Flublok Quadrivalent vaccine, 2018-2019 formulation, and 1 other intervention for Influenza. Completed, enrolled 240 participants across 3 sites.

Detailed Summary

The primary objectives of this study were: * To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (\<) 36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to \<65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (\>=) 65 years of age. * To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to \<65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults \>=65 years of age.

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartSep 10, 2018
Primary CompletionNov 12, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.9 years ago

Interventions

Fluzone Quadrivalent vaccine, 2018-2019 formulationbiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Flublok Quadrivalent vaccine, 2018-2019 formulationbiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Fluzone High-Dose vaccine, 2018-2019 formulationbiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular