NCT02258334

Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults

Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Objectives: * To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone ®High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Detailed description

Adults 18 to \< 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® Quadrivalent vaccine, 2014-2015 formulation	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone I®ntradermal vaccine, 2014-2015 formulation	0.1 mL, Intradermal
BIOLOGICAL	Fluzone® Quadrivalent vaccine, 2014-2015 formulation	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone High Dose vaccine, 2014-2015 formulation	0.5 mL, Intramuscular

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-10-07
• Last updated: 2015-10-19
• Results posted: 2015-10-19

Locations

4 sites across 1 country: United States