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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

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.

Trial Locations (23)

13210

SUNY Upstate Medical University, Syracuse

15202

Belleview Pediactric Assoc., Pittsburgh

18015

St. Luke's Hospital, Bethlehem

25701

University Physicians Internal Medicine, Huntington

27705

Duke Health Center- Pickett Road, Durham

33032

Homestead Clinical Research, Naranja

33155

Miami Children's Hospital, Miami

33606

University of South Florida College of Medicine Department of Pediatrics, Tampa

37660

Holston Medical Group, Kingsport

40503

Michael W. Simon, M.D., Lexington

44106

University Hospitals Case Medical Center, Cleveland

68134

Meridian Clinical Research LLC, Omaha

70112

Tulane University, New Orleans

72205

Arkansas Pediatric Clinic, Little Rock

72712

Children's Investigational Research Program, Bentonville

74127

Oklahoma State University Center for Health Sciences, Tulsa

84790

Dixie Pediatrics, St. George

89107

Children's Lung Specialists Ltd., Las Vegas

93637

Madera Family Medical Group, Madera

95678

Allergy Medical Group of the North Area, Roseville

96826-1032

Kapiolani Medical Center for Women and Children, Honolulu

02111

Tufts-New England Medical Center, Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY