NCT00493285

Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

Summary

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

Detailed description

The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10\^4, 10\^5, or 10\^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to \<24 months of age.

Conditions

• Respiratory Viral Infections
• Respiratory Syncytial Virus Infections
• Parainfluenza Virus 3, Human

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-534	Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50
BIOLOGICAL	MEDI-534	Multiple doses of MEDI-534 or Placebo at 10 \^5 TCID50.
BIOLOGICAL	MEDI-534	Multiple doses of MEDI-534 or Placebo at 10\^6 TCID50.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2007-06-28
• Last updated: 2012-07-19
• Results posted: 2012-04-09

Locations

30 sites across 1 country: United States