A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

Phase 1/2 Terminated 30 enrolled MedImmune LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10\^5 TCID50 when administered to children 6 to \< 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to \< 3 months of age regardless of baseline serostatus.

Timeline

Start: 2007-10
Primary completion: 2009-04
Completion: 2009-04

Outcome

Outcome not reported

Stopped (Enrollment): “The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.”

Publications

Results Bernstein DI, Falloon J, Yi T. A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants. Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MEDI-560	Vaccine	100000 unknown	Intranasal

Indications

No indication recorded.