Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Summary

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Timeline

Start

2003-09

Primary completion

2004-01

Completion

2004-07

Publications

• Results Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. doi: 10.1097/01.inf.0000180978.66362.d9.

Drugs

Indications