Influenza Clinical Trial
Official title:
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
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
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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