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

June 21, 2013 updated by: MedImmune LLC

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

6635

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1270AAN
        • Hospital General de Niños Pedro de Elizalde
      • Buenos Aires, Argentina, B1754FWE
        • Hospital Peiade Interzonal General de Augodos
      • Capital Federal, Argentina, C145AIN
        • Sanatorio Trinidad
      • Cordoba, Argentina, C5000BJH
        • Hospital Materno Neonatal
      • North Adelaide, Australia, 5006
        • Women's and Children's Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • John Hunter Children's Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Children's Hospital (Brisbane)
      • Kippa-Ring, Queensland, Australia, 4021
        • Peninsula Clinical Research Centre
      • South Brisbane, Queensland, Australia, 4101
        • Mater Mothers Hospital Raymond Terrace
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital (Melbourne)
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Princess Margaret Children's Hospital
      • Graz, Austria, A-8036
        • Universitatsklinik fur Kinder und Jugenheilkunde, Graz
      • Tulln, Austria, A-3430
        • LandesKrankenHaus Tulln, Kinderabteilung
      • Wien, Austria, A-1090
        • Allgemeines KrankenHaus Universitatsklinkiken Wein
      • Wien, Austria, A-1220
        • SMZ-Ost Donauspital Wien
      • Campinas, Brazil, 13059-900
        • Hospital e Maternidade Celso Pierro-Puccamp
      • Curitiba, Brazil, 80010-100
        • Mernidade Nossa Senhora De Fatima
      • Curitiba, Brazil, 80060-900
        • Hospital de Clinicas da UFPR
      • Porto Alegre, Brazil, 90610-000
        • Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo
      • Ribeirao Preto, Brazil, 14048-900
        • Hospital Das Clinicas Da Faculdade De Medicina
      • Sao Paulo, Brazil, 01221-020
        • Santa Casa de Misericordia de Sao Paulo
      • Sao Paulo, Brazil, 04378-500
        • Hospital e Maternidade Santa Marina
      • Sao Paulo, Brazil, 05508-900
        • Hospital Universitario de Universidade de Sao Paulo
      • Pleven, Bulgaria, 5800
        • Multifunctional Hospital for Active Treatment "Pleven"
      • Plovdiv, Bulgaria, 4000
        • University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic
      • Plovdiv, Bulgaria, 4002
        • University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics
      • Plovdiv, Bulgaria, 4003
        • Multifunctional Hospital for Active Treatment - Plovdiv
      • Rousse, Bulgaria, 7004
        • Regional Hospital of Pulmonary Diseases
      • Sofia, Bulgaria, 1309
        • Specialized Hospital for Active Treatment of Cardio-vascular Diseases
      • Sofia, Bulgaria, 1431
        • Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"
      • Sofia, Bulgaria, 1606
        • Specialized Hospital for Active Treatment of Pediatric Diseases
      • Varna, Bulgaria, 9010
        • Multifunctional Hospital for Active Treatment "St. Marina"
      • Calgary, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Charlottetown, Canada, PE C1A 8T5
        • Queen Elizabeth Hospital
      • Edmonton, Canada, AB T6G 2J3
        • University of Alberta/Stollery Children's Hospital
      • Halifax, Canada, B3K 6R8
        • Dalhousie University IWK Health Centre
      • Hamilton, Canada, L8S 4J9
        • McMaster Children's Hospital
      • Montreal, Canada, H3H 1P3
        • McGill University Health Centre Monteal Children's Hospital
      • Montreal, Canada, H3T 1C5
        • Sainte Justine Hospital
      • Ottawa, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Quebec City, Canada, G1V 4G2
        • Centre Hospitalier de l'Universite Laval
      • Saskatoon, Canada, STN 0W8
        • Royal University Hospital
      • Vancouver, Canada, V6H 3V4
        • Children's And Women's Hospital of BC
      • Victoria, Canada, V8Z 6R5
        • Victoria General Hospital
      • Windsor, Canada, N8W 1L9
        • Windsor Regional Hospital
      • Winnipeg, Canada, R3E 3P4
        • Manitoba Institute Of Child Health University of Manitoba
      • Independencia, Chile, 1196
        • Hospital San José
      • Independencia, Chile
        • Hospital Clinico de la Universidad de Chile
      • Puente Alto, Chile
        • Hospital Dr. Sótero del Río
      • Quinta Normal, Chile
        • Hospital Dr. Feliz Buines Cerda
      • Santiago, Chile
        • Hospital Clínico San Borja Arriaran
      • Santiago, Chile
        • Hospital Padre Hurtado
      • Ceske Budejovice, Czech Republic, 370 87
        • Nemocnice CB
      • Hradec Kralove, Czech Republic, 500 05
        • FN Hradec Kralove Detska klinika
      • Most, Czech Republic, 434 64
        • Nemocnice s poliklinikou v Moste
      • Olomouc, Czech Republic, 775 20
        • Fakultní nemocnice
      • Ostrava, Czech Republic, 708 52
        • FNsP Ostrava
      • Plzen-Bory, Czech Republic, 305 99
        • FN Plzen
      • Plzen-Lochotin, Czech Republic, 304 60
        • FN Plzen
      • Praha 2, Czech Republic, 128 00
        • Vfn 1.Lf Uk
      • Praha 4, Czech Republic, 140 59
        • Fakultni Thomayerova nemocnice S poliklinkou
      • Praha 4, Czech Republic, 143 00
        • Ustav pro peci o matku a dite
      • Praha 5, Czech Republic, 150 06
        • FN Motol Novorozenecke oddeleni
      • Zlin, Czech Republic, 762 75
        • Batova krajska nemocnice Zlin
      • Herning, Denmark, 7400
        • Paediatrisk Afdeling Herning Centralsygehus
      • Hillerod, Denmark, 3400
        • Hillerod Sygehus Helsevej 2
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Viborg, Denmark, 8800
        • Sygehus Viborg
      • Amiens Cedex 1, France, 80054
        • Service de Medecine Neonatale et de reanimation pediatrique
      • Angers, France, 49033
        • CHU Angers
      • Besancon, France, 25030
        • CHU de Besançon-Hôpital Saint-Jacques
      • Bordeaux, France, 33076
        • CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B
      • Chambery, France, BP1125
        • CH Chambery
      • Dijon, France, 21079
        • CHU Dijon
      • Lille, France, 59037
        • Hôpital Jeanne de Flandre
      • Marseille, France, 13915
        • CHU Nord
      • Montpellier, France, 34000
        • CHU Montpellier/Hoptial Arnaud de Villeneuve
      • Nantes, France, 44093
        • CHU de Nantes/Hospital Mere-Enfant
      • Poissy Cedex, France, 78300
        • CHI Poissy/St Germain en Laye
      • Rennes Cedex, France, 35203
        • CHU Rennes/Hopital Sud
      • Rouen Cedex, France, 76031
        • CHU Rouen
      • Strasbourg, France, 67098
        • CH Pierre Haute
      • Toulouse Cedex 9, France, BP 3119
        • CHU Toulouse-hôpital des Enfants
      • Tours Cedex, France, 37044
        • Centre Pédiatrique Gatien de Clocheville
      • Bochum, Germany, 44791
        • Ruhr-Uni St. Josef Hospital
      • Duisburg, Germany, 47055
        • Klinikum Duisburg, Wedau Kliniken
      • Dusseldorf, Germany, 40225
        • Uni-Kinderklinik
      • Erlangen, Germany, 91054
        • Klinik fur Kinder und Jugendliche
      • Freiburg, Germany, 79110
        • Zentrum Klinische Studien/Universtatsklinikum Freiburg
      • Gottingen, Germany, 37075
        • Universtatsklinikum Gottingen
      • Halle, Germany, 06120
        • Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin
      • Hannover, Germany, 30173
        • Stiftung Hannoversche
      • Heidelberg, Germany, 69120
        • Im Neuenheimer Feld 153
      • Leipzig, Germany, 04137
        • Klinik und Poliklinik und Jugendiche der Universitat Leipzig
      • Mainz, Germany, 55101
        • Universitatskinderlinik/Zentrum Fur klinische Studien
      • Muenchen, Germany, 80337
        • Kinderklinik und Kinderpoliklinik
      • Munchen, Germany, 81545
        • Stadtisches Krankenhaus Muchen-Harlaching
      • Oberhausen, Germany, 46047
        • Evangelischisches Krankenhaus
      • Oldenberg, Germany, 26133
        • Klinikum Oldenberg
      • Rosenheim, Germany, 83022
        • Klinikum Rosenheim
      • Sankt Augustin, Germany, 53757
        • Asklepios Kinderklinik Sankt Augustin GmbH
      • Athens, Greece, 11527
        • "P&A Kyriakou" Children's hospital
      • Athens, Greece, 11527
        • Aghia Sofia Children hospital
      • Thessaloniki, Greece, 54636
        • Aristotele University of Thessaloniki, General "AXEPA" Hospital
      • Thessaloniki, Greece, 54642
        • Hippokration Hospital, University of Thessaloniki
      • Thessaloniki, Greece, 56429
        • General hospital "Papageorgiou"
      • Budapest, Hungary, 1088
        • Semmelweis University
      • Budapest, Hungary, 1083
        • Semmelweis Univ.
      • Budapest, Hungary, 1092
        • Schopf-Merei Agost Hospital
      • Budapest, Hungary, 1094
        • Semmelweis Univ.
      • Debrecen, Hungary, 4012
        • DEOEC Neonatology Division
      • Debrecen, Hungary, 4012
        • DEOEC, Dept. of Pediatry
      • Gyor, Hungary, 9023
        • Petz Aladár Teaching Hospital
      • Miskolc, Hungary, 3501
        • Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Hospital
      • Pecs, Hungary, 7623
        • University of Pecs
      • Pecs, Hungary, 7624
        • Univ. of Pecs
      • Veszprem, Hungary, 8200
        • CSolnoky ferenc Hospital
      • Reykjavik, Iceland, 101
        • Children's hospital, Landspitali University Hospital
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Ashkelon, Israel, 78306
        • Barzilai Medical Center
      • Beer-Sheva, Israel, 84101
        • Soroka Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 31048
        • Bnei Zion Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Ein-Kerem Medical Center
      • Kfar-Saba, Israel, 44281
        • Sapir Medical Center
      • Natanya, Israel
        • Laniado Medical Center
      • Petach Tikva, Israel, 49100
        • Schneider Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel-Aviv, Israel, 64239
        • Sourasky medical center (Ichilov)
      • Tel-Hashomer, Israel, 52621
        • Chaim Sheba Medical Center
      • Tiberia, Israel
        • Poria Medical Center
      • Ancona, Italy, 60123
        • Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"
      • Bergamo, Italy, 24128
        • Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale
      • Bologna, Italy, 40139
        • Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi
      • Bolzano, Italy, 39100
        • Ospedale Generale di Bolzano
      • Brescia, Italy, 25123
        • Spedali Civili di Brescia
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
      • Foggia, Italy, 71100
        • Azienda Ospedaliera Universitaria
      • Imola, Italy, 40026
        • Azienda USL di Imola - Ospedale di Imola
      • Lecco, Italy, 23900
        • Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"
      • Messina, Italy, 98100
        • Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
      • Monza, Italy, 20052
        • Azienda Ospedaliera San Gerardo
      • Parma, Italy, 43100
        • Azienda Ospedaliera di Parma
      • Pisa, Italy, 56100
        • Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
      • Torino, Italy, 10126
        • Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna
      • Udine, Italy, 33100
        • Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale
      • Auckland, New Zealand
        • Middlemore Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Hamilton, New Zealand
        • Waikato Hospital
      • Palmerston North, New Zealand
        • Palmerston North Hospital
      • Białystok, Poland, 15-274
        • Klinika Neonatologii AM w Białymstoku
      • Bydgoszcz, Poland, 85-168
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka
      • Bydgoszcz, Poland, 85-667
        • Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka
      • Częstochowa, Poland, 42-200
        • Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy
      • Gdańsk, Poland, 80-952
        • Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii
      • Gdynia, Poland, 81-519
        • Szpital Morski im. PCK, Oddział Dziecięcy
      • Krakow, Poland, 31-501
        • Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie
      • Leczna, Poland, 21-010
        • Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.
      • Lublin, Poland, 20-093
        • Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie
      • Poznań, Poland, 60-535
        • Katedra i Klinika Neonatologii AM w Poznaniu
      • Szczecin, Poland, 71-252
        • II Klinika Chorób Dzieci PAM, Samodzielny Publiczny
      • Warsaw, Poland, 00-315
        • Klinika Neonatologii AM w Warszawie
      • Warszawa, Poland, 04-736
        • Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka
      • Łódź, Poland, 91-738
        • Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii
      • Łódź, Poland, 93-338
        • Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki
      • Moscow, Russian Federation, 103001
        • Pediatric City Hospital #13
      • Moscow, Russian Federation, 117049
        • Morozovsky Pediatric City Hospital
      • Smolensk, Russian Federation, 214018
        • Smolensk State Medical Academy
      • St. Petersburg, Russian Federation, 193312
        • St. Petersburg City Outpatient Hospital #45
      • St. Petersburg, Russian Federation, 194100
        • Saint-Petersburg State Pediatric Medical Academy
      • St. Petersburg, Russian Federation, 194100
        • St. Petersburg State Pediatric Medical Academy
      • St. Petersburg, Russian Federation, 198205
        • Pediatric City Hospital #1
      • Barcelona, Spain, 08036
        • Hospital Clinic y Maternistat - Barcelona
      • Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu (Barcelona)
      • Cruces, Spain, 48903
        • Hospital De Cruces
      • Córdoba, Spain, 14004
        • Hospital Reina Sofía
      • Gerona, Spain
        • Hospital Josep Trueta
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Guipuzcoa, Spain, 20014
        • Hospital de Donostia (San Sebastian)
      • Jaén, Spain, 23007
        • Hospital Materno Infantil deJaén
      • Jerez, Spain, 11407
        • Hospital General de Jerez
      • La Coruña, Spain, 15006
        • Hospital Juan Canalejo
      • Las Palmas de Gran Canaria, Spain
        • Hospital Materno Infantil de Canarias
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Hospital La Paz- Madrid
      • Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Malaga, Spain, 29011
        • Hospital Materno Infantil/Neumología pediátrica
      • Oviedo, Spain, 33006
        • Hospital Central de Asturias
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santiago de Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago
      • Sevilla, Spain, 41071
        • Hospital Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Maternal Virgen del Rocío
      • Tarragona, Spain, 43007
        • Hospital Joan XXIII
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe Maternidad
      • Vigo, Spain, 36204
        • Hospital Xeral-Cíes
      • Eskilstuna, Sweden, 631 88
        • Mälarsjukhuset
      • Goteborg, Sweden, 41685
        • The Queen Silvia Children's Hospital
      • Stockholm, Sweden, 182 88
        • Danderyds sjukhus
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital Solna
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital
      • Ankara, Turkey, 06100
        • Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi
      • Ankara, Turkey
        • Ankara Universitesi
      • Izmir, Turkey, 35100
        • Ege Universitesi Tıp Fakultesi
      • Izmir, Turkey, 35340
        • Dokuz Eylül Üniversitesi Tıp Fakültesi
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Dumfries, United Kingdom, DG1 4AP
        • Dumfries and Galloway Royal Infirmary
      • Dundee, United Kingdom, DD1 9SY
        • Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital
      • Gillingham Kent, United Kingdom, ME7 5NY
        • Medway Maritime Hospital
      • Hants, United Kingdom, SO16 5YA
        • Princess Anne Hospital
      • Leeds, United Kingdom, LS2 9NS
        • Claredon Wing, Leeds General Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • St James' University Hospital
      • Middlesborough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre Nottingham University Hospital
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital
      • Winchester, United Kingdom, SO22 5DG
        • Royal Hampshire County Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Pike Road, Alabama, United States, 35233
        • Alabama Neonatal Medicine OC
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Medical Center
    • Arkansas
      • Benton, Arkansas, United States, 72015
        • Central Arkansas Pediatric Clinic, PA
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, P.A.
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Pediatric Clinic
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Children's Clinic, PA
    • California
      • Long Beach, California, United States, 90806
        • Miller Children's Hospital
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles
      • Oakland, California, United States, 94609
        • Children's Hospital of Oakland
      • Oakland, California, United States, 94611
        • Kaiser Permanente Health Care Plan
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Diego, California, United States, 92103
        • University of California
      • San Diego, California, United States, 92123
        • Children's Hospital San Diego
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Jose, California, United States, 95728
        • Santa Clara Valley Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
      • Stamford, Connecticut, United States, 06920
        • Pediatric Pulmonology, LLC
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • A. I. Dupont Hospital For Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at the University of Florida
      • Jacksonville, Florida, United States, 32207
        • The Nemours Children's Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Medical Center
      • Orlando, Florida, United States, 32801
        • Nemours Children's Clinic Biomedical Research
      • Tampa, Florida, United States, 33606
        • Univ. S. Florida Pediatrics Ambulatory Care Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Atlanta, Georgia, United States, 30342
        • Georgia Pediatric Pulmonology Associates
      • Augusta, Georgia, United States, 30912
        • The Medical College Of Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Woman and Children
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
      • Cook, Illinois, United States, 60453
        • Advocate Hope Children's Hospital
      • Park Ridge, Illinois, United States, 60068
        • Lutheran General Children's Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • James Whitcomb Riley Hospital for Children
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Louisiana State University MidCity Clinic
      • New Orleans, Louisiana, United States, 70112
        • Tulane Hospital for Children
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts-New England Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Mott Children's Hospital
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, United States, 48236
        • St. John Hospital & Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • DeVos Children's Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic
      • St. Paul, Minnesota, United States, 55102
        • Children's Healthcare D.B.A. Hospitals & Clinics
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center Pediatric
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Children's Lung Specialist, Ltd
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Medical School
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Newark, New Jersey, United States, 07103
        • New Jersey Medical School
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10457
        • Bronx-Lebanon Hospital Center
      • Brooklyn, New York, United States, 11201
        • The Brooklyn Hospital Center
      • Buffalo, New York, United States, 14222
        • Women & Children's Hospital
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hospital
      • Poughkeepsie, New York, United States, 12603
        • The Children's Medical Group
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794
        • University Hospital State University of New York at Stony Brook Department of Pediatrics
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Crouse Hospital NICU
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina-School of Medicine
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27858
        • East Carolina University School of Medicine
      • Raleigh, North Carolina, United States, 27615
        • Raleigh Pediatric Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center of Akron
      • Boardman, Ohio, United States, 44512
        • Beehly Medical Park Women's and Children's Pav.
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Col. of Med.
      • Cleveland, Ohio, United States, 44109
        • Metro Health Medical Center
      • Columbus, Ohio, United States, 43205
        • Pediatric Clinical Trials International, Inc.
      • Dayton, Ohio, United States, 45404
        • Children's Medical Center
      • Mahaning, Ohio, United States, 44501
        • Tod Children's Hospital
      • Toledo, Ohio, United States, 43606
        • Toledo Children's Hospital
      • Toledo, Ohio, United States, 43608
        • St. Vincent Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5066
        • Children's Hospital of Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Saint Francis Hospital EOPC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • LeHigh Valley Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center- JW Children's Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson-duPont Children's Health Program
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sioux Valley Hospital University of South Dakota Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • LeBonheur Children's Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390
        • Univ. Of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • University of Texas Houston Medical School
      • Lubbock, Texas, United States, 79415
        • Texas Tech Health Sciences Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, United States, 85113
        • Primary Children's Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Hospital
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • University Physicians
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53210
        • St. Joseph's Hospital
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital, Inc
      • Wauwatosa, Wisconsin, United States, 53226
        • Children's Corporate Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: palivizumab
15 mg/kg administered intramuscularly for 5 monthly doses
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Other Names:
  • Synagis
Experimental: motavizumab (MEDI-524)
15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Other Names:
  • MEDI-524

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of RSV Hospitalization (Includes Deaths by RSV)
Time Frame: Days 0 - 150
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).
Days 0 - 150
Number of Participants Reporting Any Adverse Events (AEs)
Time Frame: Days 0 - 150
Number of participants reporting one or more AEs
Days 0 - 150
Number of Participants Reporting Any Related AEs
Time Frame: Days 0 - 150
Number of participants reporting one or more AEs considered related to study drug by the investigator
Days 0 - 150
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Time Frame: Days 0 - 150
Number of participants reporting one or more SAEs
Days 0 - 150
Number of Participants Reporting Any Related SAEs
Time Frame: Days 0 - 150
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Days 0 - 150
Number of Participants Reporting AEs by Highest Severity Grade
Time Frame: Days 0 - 150
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Days 0 - 150
Number of Participants Who Discontinued Study Drug Due to AEs
Time Frame: Days 0 - 150
Days 0 - 150
Number of Participants Who Died
Time Frame: Days 0 - 150
Days 0 - 150
Number of Participants Reporting Changes in Vital Signs From Baseline
Time Frame: Days 0 - 150
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Days 0 - 150

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
Time Frame: Day 0 - 150
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.
Day 0 - 150
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
Time Frame: Days 0 - 150
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.
Days 0 - 150
The Incidence of Medically-attended Otitis Media (OM) Infections
Time Frame: Days 0 - 150
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.
Days 0 - 150
The Frequency of Prescribed Antibiotics for Medically-attended LRI
Time Frame: Days 0 - 150
The average number of presciptions per event per subject was summarized for each treatment group.
Days 0 - 150
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
Time Frame: Days 0 - 150
The average number of presciptions per event per subject was summarized for each treatment group.
Days 0 - 150
The Number of Participants With Anti-motavizumab Antibodies
Time Frame: Day 0 - 120
Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.
Day 0 - 120
The Serum Concentrations of Motavizumab at Day 0
Time Frame: Day 0
Mean serum concentrations of motavizumab at Day 0
Day 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
Time Frame: 30 days post Dose 1
Mean serum concentrations of motavizumab at 30 days post Dose 1
30 days post Dose 1
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
Time Frame: 30 days post Dose 2
Mean serum concentrations of motavizumab at 30 days post Dose 2
30 days post Dose 2
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
Time Frame: 30 days post Dose 3
Mean serum concentrations of motavizumab at 30 days post Dose 3
30 days post Dose 3
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
Time Frame: 30 days post Dose 4
Mean serum concentrations of motavizumab at 30 days post Dose 4
30 days post Dose 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: M Pamela Griffin, MD, MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria

August 10, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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