AzTrials
AzTrials

Respiratory Syncytial Virus InfectionsPhase 3NCT00129766

Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

A Phase 3 study testing motavizumab (MEDI-524) and palivizumab in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 344 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. Read more about this study

Who is it for?
Ages Up to 24 months
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
motavizumab (MEDI-524) and palivizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,635 participants
Where
344 sitesin 24 countries
Study dates
Nov 2004to May 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
  • OR:
  • 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

Who cannot join

  • Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
  • Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
  • Life expectancy < 6 months
  • Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
  • Known renal impairment
  • Known hepatic dysfunction
Show all 15Show fewer
  • Chronic seizure or evolving or unstable neurologic disorder
  • Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
  • Known immunodeficiency
  • Mother with HIV infection (unless the child has been proven to be not infected)
  • Known allergy to Ig products
  • Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
  • Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
  • Previous receipt of RSV vaccines
  • Participation in other investigational drug product studies

Trial locations and contacts

344 sites in 24 countries.

344 sites in 24 countries

United States120 sites

  • Children's Hospital Medical Center Of Akron

    Akron, Ohio, 44308

  • Albany Medical Center

    Albany, New York, 12208

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • University of Michigan Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Emory University School Of Medicine

    Atlanta, Georgia, 30322

  • Georgia Pediatric Pulmonology Associates

    Atlanta, Georgia, 30342

  • The Medical College Of Georgia

    Augusta, Georgia, 30912

  • University Of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Louisiana State University MidCity Clinic

    Baton Rouge, Louisiana, 70806

  • Central Arkansas Pediatric Clinic, PA

    Benton, Arkansas, 72015

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35233

  • Beehly Medical Park Women's and Children's Pav.

    Boardman, Ohio, 44512

  • Tufts-New England Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • The Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Women & Children's Hospital

    Buffalo, New York, 14222

  • University of North Carolina-School of Medicine

    Chapel Hill, North Carolina, 27516

  • MUSC

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia Hospital

    Charlottesville, Virginia, 22908

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • University of Cincinnati Col. of Med.

    Cincinnati, Ohio, 45267

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

  • Pediatric Clinical Trials International, Inc.

    Columbus, Ohio, 43205

  • Advocate Hope Children's Hospital

    Cook, Illinois, 60453

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Univ. Of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Medical Center- JW Children's Hospital

    Danville, Pennsylvania, 17822

  • Children's Medical Center

    Dayton, Ohio, 45404

  • Children's Hospital

    Denver, Colorado, 80218

  • Children's Hospital Of Michigan

    Detroit, Michigan, 48201

  • St. John Hospital & Medical Center

    Detroit, Michigan, 48236

  • St. Mary's Duluth Clinic

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Shands Hospital At The University Of Florida

    Gainesville, Florida, 32610

  • DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Kapiolani Medical Center for Woman and Children

    Honolulu, Hawaii, 96826

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University Of Texas Houston Medical School

    Houston, Texas, 77030

  • University Physicians

    Huntington, West Virginia, 25701

  • James Whitcomb Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • The Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • The Children's Clinic Of Jonesboro, P.A.

    Jonesboro, Arkansas, 72401

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Children's Lung Specialist, Ltd

    Las Vegas, Nevada, 89107

  • Dartmouth Medical School

    Lebanon, New Hampshire, 03756

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas, 72202

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Little Rock Children's Clinic, PA

    Little Rock, Arkansas, 72205

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 90027

  • University of Louisville

    Louisville, Kentucky, 40202

  • Texas Tech Health Sciences Center

    Lubbock, Texas, 79415

  • Tod Children's Hospital

    Mahaning, Ohio, 44501

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Lebonheur Children's Medical Center

    Memphis, Tennessee, 38103

  • University Of Miami Medical Center

    Miami, Florida, 33136

  • St. Joseph's Hospital

    Milwaukee, Wisconsin, 53210

  • Winthrop University Hospital

    Mineola, New York, 11501

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • Tulane Hospital for Children

    New Orleans, Louisiana, 70112

  • New Jersey Medical School

    Newark, New Jersey, 07103

  • Children's Hospital of Oakland

    Oakland, California, 94609

  • Kaiser Permanente Health Care Plan

    Oakland, California, 94611

  • Children's Hospital Of Oklahoma

    Oklahoma City, Oklahoma, 73104-5066

  • University of Nebraska Medical Center Pediatric

    Omaha, Nebraska, 68198

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Nemours Children's Clinic Biomedical Research

    Orlando, Florida, 32801

  • Lutheran General Children's Hospital

    Park Ridge, Illinois, 60068

  • The Children's Hospital Of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Jefferson-duPont Children's Health Program

    Philadelphia, Pennsylvania, 19107

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Maricopa Medical Center

    Phoenix, Arizona, 85008

  • Alabama Neonatal Medicine OC

    Pike Road, Alabama, 35233

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • The Children's Medical Group

    Poughkeepsie, New York, 12603

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Raleigh Pediatric Associates

    Raleigh, North Carolina, 27615

  • VCU Medical Center

    Richmond, Virginia, 23298

  • University Of Rochester Medical Center

    Rochester, New York, 14642

  • Children's Healthcare D.B.A. Hospitals & Clinics

    Saint Paul, Minnesota, 55102

  • Primary Children's Medical Center

    Salt Lake City, Utah, 85113

  • University Of Texas Health Science Center

    San Antonio, Texas, 78229

  • University of California

    San Diego, California, 92103

  • Children's Hospital San Diego

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Santa Clara Valley Medical Center

    San Jose, California, 95728

  • Sioux Valley Hospital University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Pediatric Pulmonology, LLC

    Stamford, Connecticut, 06920

  • University Hospital State University of New York at Stony Brook Department of Pediatrics

    Stony Brook, New York, 11794

  • Crouse Hospital NICU

    Syracuse, New York, 13210

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Univ. S. Florida Pediatrics Ambulatory Care Center

    Tampa, Florida, 33606

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Bronx-Lebanon Hospital Center

    The Bronx, New York, 10457

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Toledo Children's Hospital

    Toledo, Ohio, 43606

  • St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Saint Francis Hospital EOPC

    Tulsa, Oklahoma, 74136

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Waukesha Memorial Hospital, Inc

    Waukesha, Wisconsin, 53188

  • Children's Corporate Center

    Wauwatosa, Wisconsin, 53226

  • A. I. Dupont Hospital For Children

    Wilmington, Delaware, 19803

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain25 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Hospital Clinic y Maternistat - Barcelona

    Barcelona, 08036

  • Hospital Sant Joan de Déu (Barcelona)

    Barcelona, 08950

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital de Cruces

    Cruces, 48903

  • Hospital Josep Trueta

    Girona

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital de Donostia (San Sebastian)

    Guipuzcoa, 20014

  • Hospital Materno Infantil deJaén

    Jaén, 23007

  • Hospital General de Jerez

    Jerez de la Frontera, 11407

  • Hospital Materno Infantil de Canarias

    Las Palmas de Gran Canaria

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz- Madrid

    Madrid, 28040

  • Hospital Severo Ochoa

    Madrid, 28911

  • Hospital Materno Infantil/Neumología pediátrica

    Málaga, 29011

  • Hospital Central de Asturias

    Oviedo, 33006

  • Hospital Clinico de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Maternal Virgen del Rocío

    Seville, 41013

  • Hospital Virgen Macarena

    Seville, 41071

  • Hospital Joan XXIII

    Tarragona, 43007

  • Hospital Universitario La Fe Maternidad

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Xeral-Cíes

    Vigo, 36204

Other trials in Spain

Germany17 sites

  • Ruhr-Uni St. Josef Hospital

    Bochum, 44791

  • Klinikum Duisburg, Wedau Kliniken

    Duisburg, 47055

  • Uni-Kinderklinik

    Düsseldorf, 40225

  • Klinik fur Kinder und Jugendliche

    Erlangen, 91054

  • Zentrum Klinische Studien/Universtatsklinikum Freiburg

    Freiburg im Breisgau, 79110

  • Universtatsklinikum Gottingen

    Göttingen, 37075

  • Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin

    Halle, 06120

  • Stiftung Hannoversche

    Hanover, 30173

  • Im Neuenheimer Feld 153

    Heidelberg, 69120

  • Klinik und Poliklinik und Jugendiche der Universitat Leipzig

    Leipzig, 04137

  • Universitatskinderlinik/Zentrum Fur klinische Studien

    Mainz, 55101

  • Kinderklinik und Kinderpoliklinik

    München, 80337

  • Stadtisches Krankenhaus Muchen-Harlaching

    München, 81545

  • Evangelischisches Krankenhaus

    Oberhausen, 46047

  • Klinikum Oldenberg

    Oldenberg, 26133

  • Klinikum Rosenheim

    Rosenheim, 83022

  • Asklepios Kinderklinik Sankt Augustin GmbH

    Sankt Augustin, 53757

Other trials in Germany

France16 sites

  • Service de Medecine Neonatale et de reanimation pediatrique

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • CHU de Besancon-Hopital Saint-Jacques

    Besançon, 25030

  • CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B

    Bordeaux, 33076

  • CH Chambery

    Chambéry, BP1125

  • CHU Dijon

    Dijon, 21079

  • Hopital Jeanne de Flandre

    Lille, 59037

  • CHU Nord

    Marseille, 13915

  • CHU Montpellier/Hoptial Arnaud de Villeneuve

    Montpellier, 34000

  • CHU de Nantes/Hospital Mere-Enfant

    Nantes, 44093

  • CHI Poissy/St Germain en Laye

    Poissy, 78300

  • CHU Rennes/Hopital Sud

    Rennes, 35203

  • CHU Rouen

    Rouen, 76031

  • CH Pierre Haute

    Strasbourg, 67098

  • CHU Toulouse-Hopital des Enfants

    Toulouse, BP 3119

  • Centre Pediatrique Gatien de Clocheville

    Tours, 37044

Other trials in France

Israel16 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78306

  • Soroka Medical Center

    Beersheba, 84101

  • Bnei Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 91120

  • Sapir Medical Center

    Kfar Saba, 44281

  • Laniado Medical Center

    Netanya

  • Schneider Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Sourasky Medical Center (Ichilov)

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Poria Medical Center

    Tiberias

Other trials in Israel

Italy15 sites

  • Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"

    Ancona, 60123

  • Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale

    Bergamo, 24128

  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi

    Bologna, 40139

  • Ospedale Generale di Bolzano

    Bolzano, 39100

  • Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, 12100

  • Azienda Ospedaliera Universitaria

    Foggia, 71100

  • Azienda USL di Imola - Ospedale di Imola

    Imola, 40026

  • Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"

    Lecco, 23900

  • Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

    Messina, 98100

  • Azienda Ospedaliera San Gerardo

    Monza, 20052

  • Azienda Ospedaliera di Parma

    Parma, 43100

  • Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56100

  • Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna

    Torino, 10126

  • Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale

    Udine, 33100

Other trials in Italy

Poland15 sites

  • Klinika Neonatologii AM w Białymstoku

    Bialystok, 15-274

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka

    Bydgoszcz, 85-168

  • Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka

    Bydgoszcz, 85-667

  • Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy

    Częstochowa, 42-200

  • Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii

    Gdansk, 80-952

  • Szpital Morski im. PCK, Oddział Dziecięcy

    Gdynia, 81-519

  • Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie

    Krakow, 31-501

  • Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.

    Łęczna, 21-010

  • Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii

    Lodz, 91-738

  • Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie

    Lublin, 20-093

  • Katedra i Klinika Neonatologii AM w Poznaniu

    Poznan, 60-535

  • II Klinika Chorób Dzieci PAM, Samodzielny Publiczny

    Szczecin, 71-252

  • Klinika Neonatologii AM w Warszawie

    Warsaw, 00-315

  • Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04-736

Other trials in Poland

Canada14 sites

  • Alberta Children's Hospital

    Calgary, T2T 5C7

  • Queen Elizabeth Hospital

    Charlottetown, PE C1A 8T5

  • University Of Alberta/Stollery Children's Hospital

    Edmonton, AB T6G 2J3

  • Dalhousie University IWK Health Centre

    Halifax, B3K 6R8

  • Mcmaster Children's Hospital

    Hamilton, L8S 4J9

  • McGill University Health Centre Monteal Children's Hospital

    Montreal, H3H 1P3

  • Sainte Justine Hospital

    Montreal, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, K1H 8L1

  • Centre Hospitalier de L'Universite Laval

    Québec, G1V 4G2

  • Royal University Hospital

    Saskatoon, STN 0W8

  • Children's And Women's Hospital of BC

    Vancouver, V6H 3V4

  • Victoria General Hospital

    Victoria, V8Z 6R5

  • Windsor Regional Hospital

    Windsor, N8W 1L9

  • Manitoba Institute Of Child Health University of Manitoba

    Winnipeg, R3E 3P4

Other trials in Canada

Czechia12 sites

  • Nemocnice CB

    České Budějovice, 370 87

  • FN Hradec Kralove Detska klinika

    Hradec Králové, 500 05

  • Nemocnice s poliklinikou v Moste

    Most, 434 64

  • Fakultni nemocnice

    Olomouc, 775 20

  • FNsP Ostrava

    Ostrava, 708 52

  • FN Plzen

    Plzen-Bory, 305 99

  • FN Plzen

    Plzen-Lochotin, 304 60

  • Vfn 1.Lf Uk

    Prague, 128 00

  • Fakultni Thomayerova nemocnice S poliklinkou

    Prague, 140 59

  • Ustav pro peci o matku a dite

    Prague, 143 00

  • FN Motol Novorozenecke oddeleni

    Prague, 150 06

  • Batova krajska nemocnice Zlin

    Zlín, 762 75

Other trials in Czechia

Hungary12 sites

  • Semmelweis Univ.

    Budapest, 1083

  • Semmelweis University

    Budapest, 1088

  • Schopf-Merei Agost Hospital

    Budapest, 1092

  • Semmelweis Univ.

    Budapest, 1094

  • DEOEC Neonatology Division

    Debrecen, 4012

  • DEOEC, Dept. of Pediatry

    Debrecen, 4012

  • Petz Aladar Teaching Hospital

    Győr, 9023

  • Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza

    Miskolc, 3501

  • Josa Andras Hospital

    Nyíregyháza, 4400

  • University of Pecs

    Pécs, 7623

  • Univ. of Pecs

    Pécs, 7624

  • Csolnoky Ferenc Hospital

    Veszprém, 8200

Other trials in Hungary

United Kingdom11 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Dumfries and Galloway Royal Infirmary

    Dumfries, DG1 4AP

  • Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital

    Dundee, DD1 9SY

  • Medway Maritime Hospital

    Gillingham Kent, ME7 5NY

  • Princess Anne Hospital

    Hants, SO16 5YA

  • Claredon Wing, Leeds General Infirmary

    Leeds, LS2 9NS

  • St James' University Hospital

    Leeds, LS9 7TF

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Queen's Medical Centre Nottingham University Hospital

    Nottingham, NG7 2UH

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG

Other trials in United Kingdom

Australia10 sites

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Royal Children's Hospital (Brisbane)

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Peninsula Clinical Research Centre

    Kippa-Ring, Queensland, 4021

  • John Hunter Children's Hospital

    New Lambton, New South Wales, 2305

  • Women's and Children's Hospital

    North Adelaide, 5006

  • Royal Children's Hospital (Melbourne)

    Parkville, Victoria, 3052

  • Mater Mothers Hospital Raymond Terrace

    South Brisbane, Queensland, 4101

  • Princess Margaret Children's Hospital

    Subiaco, Western Australia, 6008

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Bulgaria9 sites

  • Multifunctional Hospital for Active Treatment "Pleven"

    Pleven, 5800

  • University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic

    Plovdiv, 4000

  • University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics

    Plovdiv, 4002

  • Multifunctional Hospital for Active Treatment - Plovdiv

    Plovdiv, 4003

  • Regional Hospital of Pulmonary Diseases

    Rousse, 7004

  • Specialized Hospital for Active Treatment of Cardio-vascular Diseases

    Sofia, 1309

  • Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"

    Sofia, 1431

  • Specialized Hospital for Active Treatment of Pediatric Diseases

    Sofia, 1606

  • Multifunctional Hospital for Active Treatment "St. Marina"

    Varna, 9010

Other trials in Bulgaria

Brazil8 sites

  • Hospital e Maternidade Celso Pierro-Puccamp

    Campinas, 13059-900

  • Mernidade Nossa Senhora De Fatima

    Curitiba, 80010-100

  • Hospital De Clinicas Da UFPR

    Curitiba, 80060-900

  • Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo

    Porto Alegre, 90610-000

  • Hospital Das Clinicas Da Faculdade De Medicina

    Ribeirão Preto, 14048-900

  • Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

  • Hospital e Maternidade Santa Marina

    São Paulo, 04378-500

  • Hospital Universitario de Universidade de Sao Paulo

    São Paulo, 05508-900

Other trials in Brazil

Russia7 sites

  • Pediatric City Hospital #13

    Moscow, 103001

  • Morozovsky Pediatric City Hospital

    Moscow, 117049

  • St. Petersburg City Outpatient Hospital #45

    Saint Petersburg, 193312

  • Saint-Petersburg State Pediatric Medical Academy

    Saint Petersburg, 194100

  • St. Petersburg State Pediatric Medical Academy

    Saint Petersburg, 194100

  • Pediatric City Hospital #1

    Saint Petersburg, 198205

  • Smolensk State Medical Academy

    Smolensk, 214018

Other trials in Russia

Chile6 sites

  • Hospital San Jose

    Independencia, 1196

  • Hospital Clinico de la Universidad de Chile

    Independencia

  • Hospital Dr. Sotero Del Rio

    Puente Alto

  • Hospital Dr. Feliz Buines Cerda

    Quinta Normal

  • Hospital Clinico San Borja Arriaran

    Santiago

  • Hospital Padre Hurtado

    Santiago

Other trials in Chile

Greece5 sites

  • "P&A Kyriakou" Children's hospital

    Athens, 11527

  • Aghia Sofia Children hospital

    Athens, 11527

  • Aristotele University of Thessaloniki, General "AXEPA" Hospital

    Thessaloniki, 54636

  • Hippokration Hospital, University of Thessaloniki

    Thessaloniki, 54642

  • General hospital "Papageorgiou"

    Thessaloniki, 56429

Other trials in Greece

Sweden5 sites

  • Mälarsjukhuset

    Eskilstuna, 631 88

  • The Queen Silvia Children's Hospital

    Gothenburg, 41685

  • Karolinska University Hospital Solna

    Stockholm, 171 76

  • Danderyds Sjukhus

    Stockholm, 182 88

  • Uppsala University Hospital

    Uppsala, 751 85

Other trials in Sweden

Argentina4 sites

  • Hospital Peiade Interzonal General de Augodos

    Buenos Aires, B1754FWE

  • Hospital General De Ninos Pedro De Elizalde

    Buenos Aires, C1270AAN

  • Sanatorio Trinidad

    Capital Federal, C145AIN

  • Hospital Materno Neonatal

    Córdoba, C5000BJH

Other trials in Argentina

Austria4 sites

  • Universitatsklinik fur Kinder und Jugenheilkunde, Graz

    Graz, A-8036

  • LandesKrankenHaus Tulln, Kinderabteilung

    Tulln, A-3430

  • Allgemeines KrankenHaus Universitatsklinkiken Wein

    Vienna, A-1090

  • SMZ-Ost Donauspital Wien

    Vienna, A-1220

Other trials in Austria

Denmark4 sites

  • Paediatrisk Afdeling Herning Centralsygehus

    Herning, 7400

  • Hillerod Sygehus Helsevej 2

    Hillerød, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Sygehus Viborg

    Viborg, 8800

Other trials in Denmark

New Zealand4 sites

  • Middlemore Hospital

    Auckland

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton

  • Palmerston North Hospital

    Palmerston North

Other trials in New Zealand

Turkey (Türkiye)4 sites

  • Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi

    Ankara, 06100

  • Ankara Üniversitesi

    Ankara

  • Ege Üniversitesi Tıp Fakültesi

    Izmir, 35100

  • Dokuz Eylül Üniversitesi Tıp Fakültesi

    Izmir, 35340

Other trials in Turkey (Türkiye)

Iceland1 site

  • Children's hospital, Landspitali University Hospital

    Reykjavik, 101

Other trials in Iceland

About this study

Official title: A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Read the detailed description

A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.

Being tested
motavizumab (MEDI-524), palivizumab
Keywords
Respiratory Syncytial Virus (RSV), motavizumab, palivizumab, Synagis
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • motavizumab (MEDI-524)Biological

    Also called MEDI-524

    Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

  • palivizumabBiological

    Also called Synagis

    Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Study groups in NCT00129766
Study groupRoleWhat they receive
palivizumabActive comparator15 mg/kg administered intramuscularly for 5 monthly doses
Receives: Biological: palivizumab
motavizumab (MEDI-524)Experimental15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
Receives: Biological: motavizumab (MEDI-524)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of RSV Hospitalization (Includes Deaths by RSV)

    RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).

    Measured: Days 0 - 150

  2. Number of Participants Reporting Any Adverse Events (AEs)

    Number of participants reporting one or more AEs

    Measured: Days 0 - 150

  3. Number of Participants Reporting Any Related AEs

    Number of participants reporting one or more AEs considered related to study drug by the investigator

    Measured: Days 0 - 150

  4. Number of Participants Reporting Any Serious Adverse Events (SAEs)

    Number of participants reporting one or more SAEs

    Measured: Days 0 - 150

  5. Number of Participants Reporting Any Related SAEs

    Number of participants reporting one or more SAEs considered related to study drug by the investigator

    Measured: Days 0 - 150

  6. Number of Participants Reporting AEs by Highest Severity Grade

    Adverse events events were graded by severity; Level 1, 2, 3, or 4

    Measured: Days 0 - 150

  7. Number of Participants Who Discontinued Study Drug Due to AEs

    Measured: Days 0 - 150

  8. Number of Participants Who Died

    Measured: Days 0 - 150

  9. Number of Participants Reporting Changes in Vital Signs From Baseline

    Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs

    Measured: Days 0 - 150

Secondary outcomes (11)

  1. The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)

    LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.

    Measured: Day 0 - 150

  2. The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups

    The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.

    Measured: Days 0 - 150

  3. The Incidence of Medically-attended Otitis Media (OM) Infections

    Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.

    Measured: Days 0 - 150

  4. The Frequency of Prescribed Antibiotics for Medically-attended LRI

    The average number of presciptions per event per subject was summarized for each treatment group.

    Measured: Days 0 - 150

  5. The Frequency of Prescribed Antibiotics for Medically-attended OM Infections

    The average number of presciptions per event per subject was summarized for each treatment group.

    Measured: Days 0 - 150

  6. The Number of Participants With Anti-motavizumab Antibodies

    Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.

    Measured: Day 0 - 120

  7. The Serum Concentrations of Motavizumab at Day 0

    Mean serum concentrations of motavizumab at Day 0

    Measured: Day 0

  8. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1

    Mean serum concentrations of motavizumab at 30 days post Dose 1

    Measured: 30 days post Dose 1

  9. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2

    Mean serum concentrations of motavizumab at 30 days post Dose 2

    Measured: 30 days post Dose 2

  10. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3

    Mean serum concentrations of motavizumab at 30 days post Dose 3

    Measured: 30 days post Dose 3

  11. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4

    Mean serum concentrations of motavizumab at 30 days post Dose 4

    Measured: 30 days post Dose 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129766
Sponsor's protocol ID
MI-CP110
Status last verified
Jun 2013
First submitted
10 Aug 2005
Last updated
28 Aug 2013
Data monitoring committee
Yes

Publications

  • Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.

    PubMed 20008423

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing motavizumab (MEDI-524) and palivizumab in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 344 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 344 sites in United States, Spain, Germany, France, Israel and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of RSV Hospitalization (Includes Deaths by RSV) (time frame: Days 0 - 150). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00129766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in