NCT01044095

Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Armed Forces Research Institute of Medical Sciences, Thailand · Other Government
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FluMist® live, attenuated, intranasal seasonal influenza vaccine	FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
BIOLOGICAL	Fluzone® inactivated influenza virus vaccine	Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-07-01
• Completion: 2012-06-01
• First posted: 2010-01-07
• Last updated: 2013-07-23

Locations

1 site across 1 country: Thailand