NCT00755274

Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to \< 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to \< 5 years of age.

Detailed description

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine No Preservative: Pediatric Dose	0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
BIOLOGICAL	Influenza Virus Vaccine No Preservative: Pediatric Dose	0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-09-18
• Last updated: 2016-04-14
• Results posted: 2010-04-01

Locations

1 site across 1 country: United States