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

NCT00493285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-07-19

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Elissa Malkin, D.O. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493285 on ClinicalTrials.gov