NCT00192140

Trial to Assess the Shedding,Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age

An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 345 (planned)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 5 Years – 49 Years
• Healthy volunteers: Accepted

Summary

* To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses. * To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age. * To describe the genotypic and phenotypic stability of shed vaccine viruses. * To describe the immune responses of FluMist in individuals 5-49 years of age. * To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response

Detailed description

The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	A single intranasal dose of FluMist will be administered to approx. 300 subjects.

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-10-01
• Completion: 2005-01-01
• First posted: 2005-09-19
• Last updated: 2007-12-28

Locations

11 sites across 1 country: United States