NCT03282240

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,670 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.

Detailed description

This randomized, modified double-blind, active-controlled, multi-center trial was conducted in healthy adults (greater than and equal to \[\>=\] 65 years) to assess the safety and immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain from the primary lineage (TIV-HD1; licensed vaccine \[Fluzone® High-Dose\] for the 2017-2018 Northern Hemisphere \[NH\] influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD containing an alternate B strain).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	QIV-HD	0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
BIOLOGICAL	Licensed TIV-HD1	0.5 mL-dose was administered IM into the upper arm area.
BIOLOGICAL	Investigational TIV-HD2	0.5 mL-dose was administered IM into the upper arm area.

Timeline

• Start date: 2017-09-08
• Primary completion: 2017-11-02
• Completion: 2018-04-19
• First posted: 2017-09-13
• Last updated: 2022-04-07
• Results posted: 2019-12-17

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study