NCT01946438

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

Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines, 2013-2014 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 the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: * To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2013-2014 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. * To submit sera from selected subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

Detailed description

Participants 18 to \< 65 years of age on enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine. Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE and Serious adverse event information will be collected from Visit 1 to Visit 2. Total duration of participation in the study is approximately 21 days.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),	0.1 mL, Intradermal
BIOLOGICAL	Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)	0.5 mL, Intramuscular

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2013-09-19
• Last updated: 2014-09-25
• Results posted: 2014-09-25

Locations

4 sites across 1 country: United States