Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

665

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

October 16, 2019

Study Completion Date

October 16, 2019

Conditions
Influenza
Interventions
BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)

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

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)

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

BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)

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

BIOLOGICAL

Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)

Pharmaceutical form: Solution for injection Route of administration: IM

BIOLOGICAL

FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)

Pharmaceutical form: Solution for injection Route of administration: IM

Trial Locations (16)

30322

Investigational Site Number 8400002, Atlanta

33186

Investigational Site Number 8400001, Miami

67042

Investigational Site Number 8400013, El Dorado

67114

Investigational Site Number 8400015, Newton

67207

Investigational Site Number 8400009, Wichita

70006

Investigational Site Number 8400007, Metairie

84107

Investigational Site Number 8400003, Salt Lake City

84109

Investigational Site Number 8400012, Salt Lake City

84121

Investigational Site Number 8400005, Salt Lake City

89104

Investigational Site Number 8400010, Las Vegas

92123-1881

Investigational Site Number 8400004, San Diego

02886

Investigational Site Number 8400011, Warwick

84088-8865

Investigational Site Number 8400014, West Jordan

H3T 1C5

Investigational Site Number 1241003, Montreal

H9H 4Y6

Investigational Site Number 1241002, Pierrefonds

G1E 7G9

Investigational Site Number 1241001, Québec

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03698279 - Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age | Biotech Hunter | Biotech Hunter