NCT01967784

Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan Primary Objective: * To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation Secondary Objective: * To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation

Detailed description

Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza Vaccine (split virion, inactivated)	0.5 mL, Intramuscular

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2013-10-23
• Last updated: 2016-01-20
• Results posted: 2016-01-20

Locations

2 sites across 1 country: Taiwan