NCT02553343

A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older

Safety and Immunogenicity Trial of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above. Primary objectives: * To describe the safety profile of all subjects in each study group. * To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination. Secondary objectives: * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine. * To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.

Detailed description

All eligible participants will be randomized to receive a single injection of either one of the high-dose quadrivalent influenza vaccine formulations or one of the high-dose trivalent influenza vaccines at Day 0. They will provide blood samples for hemagglutination inhibition (HAI) testing. Safety information as solicited, unsolicited reactions, serious adverse events, including adverse events of special interest will be collected in the trial.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	High-dose quadrivalent influenza virus vaccine	0.5 mL, Intramuscular (IM), injected into the deltoid area
BIOLOGICAL	High-dose influenza virus vaccine	0.5 mL, Intramuscular (IM), injected into the deltoid area
BIOLOGICAL	High-dose trivalent inactivated influenza vaccine	0.5 mL, Intramuscular (IM), injected into the deltoid area
BIOLOGICAL	High-dose trivalent inactivated influenza vaccine	0.5 mL, Intramuscular (IM), injected into the deltoid area

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-04
• Completion: 2016-04-04
• First posted: 2015-09-17
• Last updated: 2018-02-09

Locations

9 sites across 1 country: United States