drugset / Trial / NCT01044095

Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

NCT01044095

RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2009-11
Primary completion
2010-07
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject FluMist Vaccine 0.2 ml Intranasal
Subject Influenza Virus Vaccine Vaccine 0.5 ml Intramuscular

Indications