NCT04024228 - 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 Europeans Adults 60 Years of Age and Older | Biotech Hunter

Enrollment

1,539

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

January 9, 2020

Study Completion Date

June 5, 2020

Conditions

Influenza ImmunizationHealthy Volunteers

Interventions

BIOLOGICAL

Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

BIOLOGICAL

High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM

Trial Locations (17)

2610

Investigational Site Number 0560002, Wilrijk

10629

Investigational Site Number 2760003, Berlin

10787

Investigational Site Number 2760005, Berlin

13347

Investigational Site Number 2760004, Berlin

23758

Investigational Site Number 2760002, Oldenburg in Holstein

38610

Investigational Site Number 2500001, Gières

45136

Investigational Site Number 2760001, Essen

69495

Investigational Site Number 2500003, Pierre-Bénite

75014

Investigational Site Number 2500004, Paris

90127

Investigational Site Number 3800003, Palermo

BE-9000

Investigational Site Number 0560001, Ghent

IT-16132

Investigational Site Number 3800001, Genova

3584 CX

Investigational Site Number 5280001, Utrecht

39-200

Investigational Site Number 6160001, Dębica

41-103

Investigational Site Number 6160003, Siemianowice Śląskie

43-225

Investigational Site Number 6160002, Wola

50-452

Investigational Site Number 6160004, Wroclaw

All Listed Sponsors

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY