NCT03698279

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 665 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study were: * To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. * To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.

Detailed description

Study duration per participant was approximately 180 days for participants who received one dose of vaccine and 208 days for participants who received two doses of vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-09
• Primary completion: 2019-10-16
• Completion: 2019-10-16
• First posted: 2018-10-05
• Last updated: 2022-04-04
• Results posted: 2020-06-01

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study