A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

Phase 1/2 Completed 1338 enrolled MedImmune LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.

Timeline

Start: 2008-06
Primary completion: 2012-08
Completion: 2012-08

Publications

Yang CF, Wang CK, Malkin E, Schickli JH, Shambaugh C, Zuo F, Galinski MS, Dubovsky F; Study Group; Tang RS. Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine. Vaccine. 2013 Jun 10;31(26):2822-7. doi: 10.1016/j.vaccine.2013.04.006. Epub 2013 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MEDI-534	Vaccine	10000 unknown	Intranasal
Subject	MEDI-534	Vaccine	100000 unknown	Intranasal
Subject	MEDI-534	Vaccine	1e+06 unknown	Intranasal

Indications

No indication recorded.