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

NCT00508651 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-12-30

Study results available
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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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MEDI-560

MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

BIOLOGICAL

Placebo

Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Judith Falloon, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00508651 on ClinicalTrials.gov