A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

Phase 2 Completed 200 enrolled MedImmune LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.

Timeline

Start: 2006-05-01
Primary completion: 2006-07-01
Completion: 2006-12-01

Publications

Results Mallory RM, Yi T, Ambrose CS. Shedding of Ann Arbor strain live attenuated influenza vaccine virus in children 6-59 months of age. Vaccine. 2011 Jun 10;29(26):4322-7. doi: 10.1016/j.vaccine.2011.04.022. Epub 2011 Apr 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FluMist	Vaccine	0.2 ml	Intranasal

Indications

No indication recorded.