NCT00858468

Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 9 Months
• Healthy volunteers: Accepted

Summary

Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Detailed description

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine (2004-2005 Formulation)	0.25 mL, Intramuscular
BIOLOGICAL	Influenza virus vaccine (2004-2005 Formulation)	0.25 mL, Intramuscular

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-06-01
• Completion: 2006-12-01
• First posted: 2009-03-09
• Last updated: 2016-04-14
• Results posted: 2009-07-31

Locations

8 sites across 1 country: United States