NCT03546192

Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older. The objectives were: * To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96 * To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation * To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation

Detailed description

All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit. Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone Quadrivalent Influenza Vaccine	0.5-mL, Intramuscular, SH 2015 formulation

Timeline

• Start date: 2015-06-17
• Primary completion: 2015-07-17
• Completion: 2015-07-17
• First posted: 2018-06-06
• Last updated: 2022-03-29
• Results posted: 2018-08-01

Locations

3 sites across 1 country: Philippines

Regulatory

• FDA-regulated drug study