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

PHASE3CompletedINTERVENTIONAL
Enrollment

6,635

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

May 31, 2006

Study Completion Date

May 31, 2006

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

motavizumab (MEDI-524)

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

BIOLOGICAL

palivizumab

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

Trial Locations (344)

101

Children's hospital, Landspitali University Hospital, Reykjavik

1083

Semmelweis Univ., Budapest

1088

Semmelweis University, Budapest

1092

Schopf-Merei Agost Hospital, Budapest

1094

Semmelweis Univ., Budapest

1196

Hospital San Jose, Independencia

1309

Specialized Hospital for Active Treatment of Cardio-vascular Diseases, Sofia

1431

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

1606

Specialized Hospital for Active Treatment of Pediatric Diseases, Sofia

2145

Westmead Hospital, Westmead

2305

John Hunter Children's Hospital, New Lambton

2605

The Canberra Hospital, Garran

2650

Hvidovre Hospital, Hvidovre

3052

Royal Children's Hospital (Melbourne), Parkville

3400

Hillerod Sygehus Helsevej 2, Hillerød

3501

Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza, Miskolc

4000

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

4002

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

4003

Multifunctional Hospital for Active Treatment - Plovdiv, Plovdiv

4012

DEOEC Neonatology Division, Debrecen

DEOEC, Dept. of Pediatry, Debrecen

4021

Peninsula Clinical Research Centre, Kippa-Ring

4029

Royal Children's Hospital (Brisbane), Herston

4101

Mater Mothers Hospital Raymond Terrace, South Brisbane

4400

Josa Andras Hospital, Nyíregyháza

5006

Women's and Children's Hospital, North Adelaide

5800

"Multifunctional Hospital for Active Treatment Pleven", Pleven

6008

Princess Margaret Children's Hospital, Subiaco

7000

Royal Hobart Hospital, Hobart

7004

Regional Hospital of Pulmonary Diseases, Rousse

7400

Paediatrisk Afdeling Herning Centralsygehus, Herning

7623

University of Pecs, Pécs

7624

Univ. of Pecs, Pécs

8200

Csolnoky Ferenc Hospital, Veszprém

8800

Sygehus Viborg, Viborg

9010

"Multifunctional Hospital for Active Treatment St. Marina", Varna

9023

Petz Aladar Teaching Hospital, Győr

10126

Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna, Torino

10457

Bronx-Lebanon Hospital Center, The Bronx

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

11040

Schneider Children's Hospital, New Hyde Park

11201

The Brooklyn Hospital Center, Brooklyn

11407

Hospital General de Jerez, Jerez de la Frontera

11501

Winthrop University Hospital, Mineola

11527

"P&A Kyriakou Children's hospital", Athens

Aghia Sofia Children hospital, Athens

11794

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

12100

Azienda Ospedaliera S. Croce e Carle, Cuneo

12208

Albany Medical Center, Albany

12603

The Children's Medical Group, Poughkeepsie

13210

Crouse Hospital NICU, Syracuse

SUNY Upstate Medical University, Syracuse

13915

CHU Nord, Marseille

14004

Hospital Reina Sofia, Córdoba

14222

Women & Children's Hospital, Buffalo

14642

University Of Rochester Medical Center, Rochester

15006

Hospital Juan Canalejo, A Coruña

15212

Allegheny General Hospital, Pittsburgh

15213

Children's Hospital of Pittsburgh, Pittsburgh

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

17822

Geisinger Medical Center- JW Children's Hospital, Danville

18014

Hospital Virgen de las Nieves, Granada

18015

St. Luke's Hospital, Bethlehem

18101

HaEmek Medical Center, Afula

18105

Lehigh Valley Hospital, Allentown

19010

Bryn Mawr Hospital, Bryn Mawr

19104

The Children's Hospital Of Philadelphia, Philadelphia

19107

Jefferson-duPont Children's Health Program, Philadelphia

Pennsylvania Hospital, Philadelphia

19803

A. I. Dupont Hospital For Children, Wilmington

20007

Georgetown University Medical Center, Washington D.C.

20010

Children's National Medical Center, Washington D.C.

20014

Hospital de Donostia (San Sebastian), Guipuzcoa

20052

Azienda Ospedaliera San Gerardo, Monza

21079

CHU Dijon, Dijon

21201

University Of Maryland School of Medicine, Baltimore

22908

University of Virginia Hospital, Charlottesville

23007

Hospital Materno Infantil deJaén, Jaén

23298

VCU Medical Center, Richmond

23900

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

24128

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

25030

CHU de Besancon-Hopital Saint-Jacques, Besançon

25123

Spedali Civili di Brescia, Brescia

25701

University Physicians, Huntington

26133

Klinikum Oldenberg, Oldenberg

26506

West Virginia University, Morgantown

27157

Wake Forest University School of Medicine, Winston-Salem

27516

University of North Carolina-School of Medicine, Chapel Hill

27615

Raleigh Pediatric Associates, Raleigh

27710

Duke University Medical Center, Durham

27858

East Carolina University School of Medicine, Greenville

28040

Hospital Clínico San Carlos, Madrid

Hospital La Paz- Madrid, Madrid

28203

Carolinas Medical Center, Charlotte

28911

Hospital Severo Ochoa, Madrid

29011

Hospital Materno Infantil/Neumología pediátrica, Málaga

29425

MUSC, Charleston

30173

Stiftung Hannoversche, Hanover

30322

Emory University School Of Medicine, Atlanta

30342

Georgia Pediatric Pulmonology Associates, Atlanta

30912

The Medical College Of Georgia, Augusta

31048

Bnei Zion Medical Center, Haifa

31096

Rambam Medical Center, Haifa

32207

The Nemours Children's Clinic, Jacksonville

32610

Shands Hospital At The University Of Florida, Gainesville

32801

Nemours Children's Clinic Biomedical Research, Orlando

33006

Hospital Central de Asturias, Oviedo

33076

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

33100

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

33136

University Of Miami Medical Center, Miami

33606

Univ. S. Florida Pediatrics Ambulatory Care Center, Tampa

34000

CHU Montpellier/Hoptial Arnaud de Villeneuve, Montpellier

34362

Carmel Medical Center, Haifa

35100

Ege Üniversitesi Tıp Fakültesi, Izmir

35203

CHU Rennes/Hopital Sud, Rennes

35233

University Of Alabama At Birmingham, Birmingham

Alabama Neonatal Medicine OC, Pike Road

35340

Dokuz Eylül Üniversitesi Tıp Fakültesi, Izmir

36204

Hospital Xeral-Cíes, Vigo

37007

Hospital Clinico de Salamanca, Salamanca

37044

Centre Pediatrique Gatien de Clocheville, Tours

37075

Universtatsklinikum Gottingen, Göttingen

37232

Vanderbilt University Medical Center, Nashville

38103

Lebonheur Children's Medical Center, Memphis

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

39100

Ospedale Generale di Bolzano, Bolzano

40026

Azienda USL di Imola - Ospedale di Imola, Imola

40139

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

40202

University of Louisville, Louisville

40225

Uni-Kinderklinik, Düsseldorf

41013

Hospital Maternal Virgen del Rocío, Seville

41071

Hospital Virgen Macarena, Seville

41685

The Queen Silvia Children's Hospital, Gothenburg

43007

Hospital Joan XXIII, Tarragona

43100

Azienda Ospedaliera di Parma, Parma

43205

Pediatric Clinical Trials International, Inc., Columbus

43606

Toledo Children's Hospital, Toledo

43608

St. Vincent Medical Center, Toledo

44093

CHU de Nantes/Hospital Mere-Enfant, Nantes

44109

Metro Health Medical Center, Cleveland

44281

Sapir Medical Center, Kfar Saba

44308

Children's Hospital Medical Center Of Akron, Akron

44501

Tod Children's Hospital, Mahaning

44512

Beehly Medical Park Women's and Children's Pav., Boardman

44791

Ruhr-Uni St. Josef Hospital, Bochum

45267

University of Cincinnati Col. of Med., Cincinnati

45404

Children's Medical Center, Dayton

46009

Hospital Universitario La Fe Maternidad, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

46047

Evangelischisches Krankenhaus, Oberhausen

46202

James Whitcomb Riley Hospital for Children, Indianapolis

46601

Memorial Hospital of South Bend, South Bend

47055

Klinikum Duisburg, Wedau Kliniken, Duisburg

48109

University of Michigan Mott Children's Hospital, Ann Arbor

48201

Children's Hospital Of Michigan, Detroit

48236

St. John Hospital & Medical Center, Detroit

48903

Hospital de Cruces, Cruces

49033

CHU Angers, Angers

49100

Schneider Medical Center, Petah Tikva

49503

DeVos Children's Hospital, Grand Rapids

52621

Chaim Sheba Medical Center, Tel Litwinsky

53188

Waukesha Memorial Hospital, Inc, Waukesha

53210

St. Joseph's Hospital, Milwaukee

53226

Children's Corporate Center, Wauwatosa

53757

Asklepios Kinderklinik Sankt Augustin GmbH, Sankt Augustin

54449

Marshfield Clinic, Marshfield

54636

"Aristotele University of Thessaloniki, General AXEPA Hospital", Thessaloniki

54642

Hippokration Hospital, University of Thessaloniki, Thessaloniki

55101

Universitatskinderlinik/Zentrum Fur klinische Studien, Mainz

55102

Children's Healthcare D.B.A. Hospitals & Clinics, Saint Paul

55805

St. Mary's Duluth Clinic, Duluth

56100

Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara, Pisa

56429

"General hospital Papageorgiou", Thessaloniki

57117

Sioux Valley Hospital University of South Dakota Medical Center, Sioux Falls

58100

Wolfson Medical Center, Holon

59037

Hopital Jeanne de Flandre, Lille

60068

Lutheran General Children's Hospital, Park Ridge

60123

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

60453

Advocate Hope Children's Hospital, Cook

60612

University of Illinois at Chicago, Chicago

60614

Children's Memorial Hospital, Chicago

64108

Children's Mercy Hospital, Kansas City

64132

Research Medical Center, Kansas City

64239

Sourasky Medical Center (Ichilov), Tel Aviv

67098

CH Pierre Haute, Strasbourg

68198

University of Nebraska Medical Center Pediatric, Omaha

69120

Im Neuenheimer Feld 153, Heidelberg

70112

Tulane Hospital for Children, New Orleans

70806

Louisiana State University MidCity Clinic, Baton Rouge

71100

Azienda Ospedaliera Universitaria, Foggia

72015

Central Arkansas Pediatric Clinic, PA, Benton

72202

Arkansas Children's Hospital Research Institute, Little Rock

72205

Arkansas Pediatric Clinic, Little Rock

Little Rock Children's Clinic, PA, Little Rock

72401

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

74136

Saint Francis Hospital EOPC, Tulsa

75246

Baylor University Medical Center, Dallas

75390

Univ. Of Texas Southwestern Medical Center, Dallas

76031

CHU Rouen, Rouen

76100

Kaplan Medical Center, Rehovot

76508

Scott & White Memorial Hospital, Temple

77030

Texas Children's Hospital, Houston

University Of Texas Houston Medical School, Houston

78229

University Of Texas Health Science Center, San Antonio

78300

CHI Poissy/St Germain en Laye, Poissy

78306

Barzilai Medical Center, Ashkelon

78411

Driscoll Children's Hospital, Corpus Christi

79110

Zentrum Klinische Studien/Universtatsklinikum Freiburg, Freiburg im Breisgau

79415

Texas Tech Health Sciences Center, Lubbock

80054

Service de Medecine Neonatale et de reanimation pediatrique, Amiens

80218

Children's Hospital, Denver

80337

Kinderklinik und Kinderpoliklinik, München

81545

Stadtisches Krankenhaus Muchen-Harlaching, München

83022

Klinikum Rosenheim, Rosenheim

84101

Soroka Medical Center, Beersheba

85008

Maricopa Medical Center, Phoenix

85113

Primary Children's Medical Center, Salt Lake City

89107

Children's Lung Specialist, Ltd, Las Vegas

90027

Kaiser Permanente Los Angeles, Los Angeles

90806

Miller Children's Hospital, Long Beach

91031

Shaare Zedek Medical Center, Jerusalem

91054

Klinik fur Kinder und Jugendliche, Erlangen

91120

Hadassah Ein-Kerem Medical Center, Jerusalem

92103

University of California, San Diego

92123

Children's Hospital San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

94115

California Pacific Medical Center, San Francisco

94609

Children's Hospital of Oakland, Oakland

94611

Kaiser Permanente Health Care Plan, Oakland

95728

Santa Clara Valley Medical Center, San Jose

96826

Kapiolani Medical Center for Woman and Children, Honolulu

97239

Oregon Health Sciences University, Portland

98100

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, Messina

103001

Pediatric City Hospital #13, Moscow

117049

Morozovsky Pediatric City Hospital, Moscow

193312

St. Petersburg City Outpatient Hospital #45, Saint Petersburg

194100

Saint-Petersburg State Pediatric Medical Academy, Saint Petersburg

St. Petersburg State Pediatric Medical Academy, Saint Petersburg

198205

Pediatric City Hospital #1, Saint Petersburg

214018

Smolensk State Medical Academy, Smolensk

06106

Connecticut Children's Medical Center, Hartford

06920

Pediatric Pulmonology, LLC, Stamford

02111

Tufts-New England Medical Center, Boston

02118

Boston Medical Center, Boston

01199

Baystate Medical Center, Springfield

03756

Dartmouth Medical School, Lebanon

07039

Saint Barnabas Medical Center, Livingston

07103

New Jersey Medical School, Newark

73104-5066

Children's Hospital Of Oklahoma, Oklahoma City

02903

Rhode Island Hospital, Providence

B1754FWE

Hospital Peiade Interzonal General de Augodos, Buenos Aires

C1270AAN

Hospital General De Ninos Pedro De Elizalde, Buenos Aires

C145AIN

Sanatorio Trinidad, Capital Federal

C5000BJH

Hospital Materno Neonatal, Córdoba

A-8036

Universitatsklinik fur Kinder und Jugenheilkunde, Graz, Graz

A-3430

LandesKrankenHaus Tulln, Kinderabteilung, Tulln

A-1090

Allgemeines KrankenHaus Universitatsklinkiken Wein, Vienna

A-1220

SMZ-Ost Donauspital Wien, Vienna

13059-900

Hospital e Maternidade Celso Pierro-Puccamp, Campinas

80010-100

Mernidade Nossa Senhora De Fatima, Curitiba

80060-900

Hospital De Clinicas Da UFPR, Curitiba

90610-000

Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo, Porto Alegre

14048-900

Hospital Das Clinicas Da Faculdade De Medicina, Ribeirão Preto

01221-020

Santa Casa de Misericordia de Sao Paulo, São Paulo

04378-500

Hospital e Maternidade Santa Marina, São Paulo

05508-900

Hospital Universitario de Universidade de Sao Paulo, São Paulo

T2T 5C7

Alberta Children's Hospital, Calgary

PE C1A 8T5

Queen Elizabeth Hospital, Charlottetown

AB T6G 2J3

University Of Alberta/Stollery Children's Hospital, Edmonton

B3K 6R8

Dalhousie University IWK Health Centre, Halifax

L8S 4J9

Mcmaster Children's Hospital, Hamilton

H3H 1P3

McGill University Health Centre Monteal Children's Hospital, Montreal

H3T 1C5

Sainte Justine Hospital, Montreal

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

G1V 4G2

Centre Hospitalier de L'Universite Laval, Québec

STN 0W8

Royal University Hospital, Saskatoon

V6H 3V4

Children's And Women's Hospital of BC, Vancouver

V8Z 6R5

Victoria General Hospital, Victoria

N8W 1L9

Windsor Regional Hospital, Windsor

R3E 3P4

Manitoba Institute Of Child Health University of Manitoba, Winnipeg

Unknown

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

Laniado Medical Center, Netanya

Poria Medical Center, Tiberias

Middlemore Hospital, Auckland

Dunedin Hospital, Dunedin

Waikato Hospital, Hamilton

Palmerston North Hospital, Palmerston North

Hospital Josep Trueta, Girona

Hospital Materno Infantil de Canarias, Las Palmas de Gran Canaria

Ankara Üniversitesi, Ankara

370 87

Nemocnice CB, České Budějovice

500 05

FN Hradec Kralove Detska klinika, Hradec Králové

434 64

Nemocnice s poliklinikou v Moste, Most

775 20

Fakultni nemocnice, Olomouc

708 52

FNsP Ostrava, Ostrava

305 99

FN Plzen, Plzen-Bory

304 60

FN Plzen, Plzen-Lochotin

128 00

Vfn 1.Lf Uk, Prague

140 59

Fakultni Thomayerova nemocnice S poliklinkou, Prague

143 00

Ustav pro peci o matku a dite, Prague

150 06

FN Motol Novorozenecke oddeleni, Prague

762 75

Batova krajska nemocnice Zlin, Zlín

BP1125

CH Chambery, Chambéry

BP 3119

CHU Toulouse-Hopital des Enfants, Toulouse

06120

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

04137

Klinik und Poliklinik und Jugendiche der Universitat Leipzig, Leipzig

15-274

Klinika Neonatologii AM w Białymstoku, Bialystok

85-168

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

85-667

Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka, Bydgoszcz

42-200

Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy, Częstochowa

80-952

Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii, Gdansk

81-519

Szpital Morski im. PCK, Oddział Dziecięcy, Gdynia

31-501

Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie, Krakow

91-738

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

93-338

Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki, Lodz

20-093

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

60-535

Katedra i Klinika Neonatologii AM w Poznaniu, Poznan

71-252

II Klinika Chorób Dzieci PAM, Samodzielny Publiczny, Szczecin

00-315

Klinika Neonatologii AM w Warszawie, Warsaw

04-736

Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka, Warsaw

21-010

Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c., Łęczna

08036

Hospital Clinic y Maternistat - Barcelona, Barcelona

08950

Hospital Sant Joan de Déu (Barcelona), Barcelona

631 88

Mälarsjukhuset, Eskilstuna

171 76

Karolinska University Hospital Solna, Stockholm

182 88

Danderyds Sjukhus, Stockholm

751 85

Uppsala University Hospital, Uppsala

06100

Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi, Ankara

B9 5SS

Birmingham Heartlands Hospital, Birmingham

DG1 4AP

Dumfries and Galloway Royal Infirmary, Dumfries

DD1 9SY

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

ME7 5NY

Medway Maritime Hospital, Gillingham Kent

SO16 5YA

Princess Anne Hospital, Hants

LS2 9NS

Claredon Wing, Leeds General Infirmary, Leeds

LS9 7TF

St James' University Hospital, Leeds

TS4 3BW

James Cook University Hospital, Middlesbrough

NG7 2UH

Queen's Medical Centre Nottingham University Hospital, Nottingham

S10 2TH

Sheffield Children's Hospital, Sheffield

SO22 5DG

Royal Hampshire County Hospital, Winchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY