NCT04498832View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,100

Participants

Timeline

Start Date

October 21, 2020

Primary Completion Date

January 14, 2021

Study Completion Date

January 14, 2021

Conditions
Influenza ImmunizationHealthy Volunteers
Interventions
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

Trial Locations (10)

Unknown

Investigational Site Number 3920005, Fukuoka

Investigational Site Number 3920004, Koganeishi

Investigational Site Number 3920006, Kumamoto

Investigational Site Number 3920001, Osaka

Investigational Site Number 3920003, Shinjuku-Ku

Investigational Site Number 3920008, Shinjuku-Ku

Investigational Site Number 3920009, Shinjuku-Ku

Investigational Site Number 3920002, Suita-Shi

Investigational Site Number 3920007, Toshima-Ku

Investigational Site Number 3920010, Yokohama

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

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 | Biotech Hunter | Biotech Hunter