NCT04498832

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older

Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered by Intramuscular Route Versus Standard-Dose Quadrivalent Influenza Vaccine by Subcutaneous Route in Subjects 60 Years of Age and Older in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.

Detailed description

Study duration per participant was approximately 28 days including: 1 day of screening and vaccination, a safety follow-up telephone call and an end of study visit approximately at Day 8 and 28 after vaccination, respectively.

Conditions

• Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICAL	Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-01-14
• Completion: 2021-01-14
• First posted: 2020-08-05
• Last updated: 2025-09-23
• Results posted: 2022-02-08

Locations

10 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study