drugset / Trial / NCT03617523

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

NCT03617523

Phase 4 Completed 240 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2018-09-10
Primary completion
2018-11-12
Completion
2018-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Flublok Quadrivalent vaccine Vaccine 0.5 ml Intramuscular
Subject Fluzone High-Dose vaccine Vaccine 0.5 ml Intramuscular
Subject Fluzone Quadrivalent vaccine Vaccine 0.25 ml Intramuscular
Subject Fluzone Quadrivalent vaccine Vaccine 0.5 ml Intramuscular

Indications