MedTrace Logo

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children

NCT00767416 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2016-07-20

No results posted yet for this study

Summary

The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MEDI-559

Cohort 1 (5 to \<24 months): N=80 MEDI-559 at 10\^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10\^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.

OTHER

Placebo

Cohort 1 (5 to \< 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Joseph Sliman, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

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 NCT00767416 on ClinicalTrials.gov