A Study of Influenza Virus Vaccines in Children and Adults
Summary
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.
Timeline
- Start
- 2009-10
- Primary completion
- 2009-12
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Influenza Virus Vaccine | Vaccine | 0.25 ml | Intramuscular |
| Comparator | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Quadrivalent Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |