Influenza Clinical Trial
Official title:
Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)
The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent
Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and
the 2008-2009 TIV among children and adults.
Primary Objective:
To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV)
compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among
adults.
Observational Objectives:
- To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60
years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype
QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
- To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to
<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of
2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of
age.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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