NCT03233217

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).

Detailed description

This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175 healthy Japanese adults aged 65 years and older to describe the safety profile and immune responses (geometric mean titers and seroconversion for the 4 common strains at 28 days post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC) methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC method served as a control arm.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	QIV-HD by IM	IM, injected into the upper arm (deltoid area)
BIOLOGICAL	QIV-SD by SC	SC, injected into the upper arm (posterior region)
BIOLOGICAL	QIV-HD by SC	SC, injection into the upper arm (posterior region)

Timeline

• Start date: 2017-09-15
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2017-07-28
• Last updated: 2022-04-04
• Results posted: 2019-12-17

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study