Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
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
1 other identifier
interventional
6,635
23 countries
340
Brief 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. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2004
340 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedResults Posted
Study results publicly available
August 28, 2013
CompletedAugust 28, 2013
June 1, 2013
1.5 years
August 10, 2005
June 21, 2013
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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).
Days 0 - 150
Number of Participants Reporting Any Adverse Events (AEs)
Number of participants reporting one or more AEs
Days 0 - 150
Number of Participants Reporting Any Related AEs
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)
Number of participants reporting one or more SAEs
Days 0 - 150
Number of Participants Reporting Any Related SAEs
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
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
Days 0 - 150
Number of Participants Who Died
Days 0 - 150
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
Days 0 - 150
Secondary Outcomes (11)
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
Day 0 - 150
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
Days 0 - 150
The Incidence of Medically-attended Otitis Media (OM) Infections
Days 0 - 150
The Frequency of Prescribed Antibiotics for Medically-attended LRI
Days 0 - 150
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
Days 0 - 150
- +6 more secondary outcomes
Study Arms (2)
palivizumab
ACTIVE COMPARATOR15 mg/kg administered intramuscularly for 5 monthly doses
motavizumab (MEDI-524)
EXPERIMENTAL15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
Interventions
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Eligibility Criteria
You may qualify if:
- 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:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (344)
University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Alabama Neonatal Medicine OC
Pike Road, Alabama, 35233, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Central Arkansas Pediatric Clinic, PA
Benton, Arkansas, 72015, United States
The Children's Clinic Of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Little Rock Children's Clinic, PA
Little Rock, Arkansas, 72205, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Oakland
Oakland, California, 94609, United States
Kaiser Permanente Health Care Plan
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
University of California
San Diego, California, 92103, United States
Children's Hospital San Diego
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Santa Clara Valley Medical Center
San Jose, California, 95728, United States
Children's Hospital
Denver, Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Pediatric Pulmonology, LLC
Stamford, Connecticut, 06920, United States
A. I. Dupont Hospital For Children
Wilmington, Delaware, 19803, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Shands Hospital At The University Of Florida
Gainesville, Florida, 32610, United States
The Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University Of Miami Medical Center
Miami, Florida, 33136, United States
Nemours Children's Clinic Biomedical Research
Orlando, Florida, 32801, United States
Univ. S. Florida Pediatrics Ambulatory Care Center
Tampa, Florida, 33606, United States
Emory University School Of Medicine
Atlanta, Georgia, 30322, United States
Georgia Pediatric Pulmonology Associates
Atlanta, Georgia, 30342, United States
The Medical College Of Georgia
Augusta, Georgia, 30912, United States
Kapiolani Medical Center for Woman and Children
Honolulu, Hawaii, 96826, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Advocate Hope Children's Hospital
Cook, Illinois, 60453, United States
Lutheran General Children's Hospital
Park Ridge, Illinois, 60068, United States
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Louisiana State University MidCity Clinic
Baton Rouge, Louisiana, 70806, United States
Tulane Hospital for Children
New Orleans, Louisiana, 70112, United States
University Of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital Of Michigan
Detroit, Michigan, 48201, United States
St. John Hospital & Medical Center
Detroit, Michigan, 48236, United States
DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805, United States
Children's Healthcare D.B.A. Hospitals & Clinics
Saint Paul, Minnesota, 55102, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
University of Nebraska Medical Center Pediatric
Omaha, Nebraska, 68198, United States
Children's Lung Specialist, Ltd
Las Vegas, Nevada, 89107, United States
Dartmouth Medical School
Lebanon, New Hampshire, 03756, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New Jersey Medical School
Newark, New Jersey, 07103, United States
Albany Medical Center
Albany, New York, 12208, United States
The Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Women & Children's Hospital
Buffalo, New York, 14222, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
The Children's Medical Group
Poughkeepsie, New York, 12603, United States
University Of Rochester Medical Center
Rochester, New York, 14642, United States
University Hospital State University of New York at Stony Brook Department of Pediatrics
Stony Brook, New York, 11794, United States
Crouse Hospital NICU
Syracuse, New York, 13210, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina-School of Medicine
Chapel Hill, North Carolina, 27516, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858, United States
Raleigh Pediatric Associates
Raleigh, North Carolina, 27615, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Children's Hospital Medical Center Of Akron
Akron, Ohio, 44308, United States
Beehly Medical Park Women's and Children's Pav.
Boardman, Ohio, 44512, United States
University of Cincinnati Col. of Med.
Cincinnati, Ohio, 45267, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Pediatric Clinical Trials International, Inc.
Columbus, Ohio, 43205, United States
Children's Medical Center
Dayton, Ohio, 45404, United States
Tod Children's Hospital
Mahaning, Ohio, 44501, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Children's Hospital Of Oklahoma
Oklahoma City, Oklahoma, 73104-5066, United States
Saint Francis Hospital EOPC
Tulsa, Oklahoma, 74136, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center- JW Children's Hospital
Danville, Pennsylvania, 17822, United States
The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Jefferson-duPont Children's Health Program
Philadelphia, Pennsylvania, 19107, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MUSC
Charleston, South Carolina, 29425, United States
Sioux Valley Hospital University of South Dakota Medical Center
Sioux Falls, South Dakota, 57117, United States
Lebonheur Children's Medical Center
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Univ. Of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University Of Texas Houston Medical School
Houston, Texas, 77030, United States
Texas Tech Health Sciences Center
Lubbock, Texas, 79415, United States
University Of Texas Health Science Center
San Antonio, Texas, 78229, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 85113, United States
University of Virginia Hospital
Charlottesville, Virginia, 22908, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
University Physicians
Huntington, West Virginia, 25701, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, 53210, United States
Waukesha Memorial Hospital, Inc
Waukesha, Wisconsin, 53188, United States
Children's Corporate Center
Wauwatosa, Wisconsin, 53226, United States
Hospital Peiade Interzonal General de Augodos
Buenos Aires, B1754FWE, Argentina
Hospital General De Ninos Pedro De Elizalde
Buenos Aires, C1270AAN, Argentina
Sanatorio Trinidad
Capital Federal, C145AIN, Argentina
Hospital Materno Neonatal
Córdoba, C5000BJH, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
John Hunter Children's Hospital
New Lambton, New South Wales, 2305, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Children's Hospital (Brisbane)
Herston, Queensland, 4029, Australia
Peninsula Clinical Research Centre
Kippa-Ring, Queensland, 4021, Australia
Mater Mothers Hospital Raymond Terrace
South Brisbane, Queensland, 4101, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Royal Children's Hospital (Melbourne)
Parkville, Victoria, 3052, Australia
Princess Margaret Children's Hospital
Subiaco, Western Australia, 6008, Australia
Women's and Children's Hospital
North Adelaide, 5006, Australia
Universitatsklinik fur Kinder und Jugenheilkunde, Graz
Graz, A-8036, Austria
LandesKrankenHaus Tulln, Kinderabteilung
Tulln, A-3430, Austria
Allgemeines KrankenHaus Universitatsklinkiken Wein
Vienna, A-1090, Austria
SMZ-Ost Donauspital Wien
Vienna, A-1220, Austria
Hospital e Maternidade Celso Pierro-Puccamp
Campinas, 13059-900, Brazil
Mernidade Nossa Senhora De Fatima
Curitiba, 80010-100, Brazil
Hospital De Clinicas Da UFPR
Curitiba, 80060-900, Brazil
Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo
Porto Alegre, 90610-000, Brazil
Hospital Das Clinicas Da Faculdade De Medicina
Ribeirão Preto, 14048-900, Brazil
Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020, Brazil
Hospital e Maternidade Santa Marina
São Paulo, 04378-500, Brazil
Hospital Universitario de Universidade de Sao Paulo
São Paulo, 05508-900, Brazil
Multifunctional Hospital for Active Treatment "Pleven"
Pleven, 5800, Bulgaria
University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic
Plovdiv, 4000, Bulgaria
University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics
Plovdiv, 4002, Bulgaria
Multifunctional Hospital for Active Treatment - Plovdiv
Plovdiv, 4003, Bulgaria
Regional Hospital of Pulmonary Diseases
Rousse, 7004, Bulgaria
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
Sofia, 1309, Bulgaria
Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Pediatric Diseases
Sofia, 1606, Bulgaria
Multifunctional Hospital for Active Treatment "St. Marina"
Varna, 9010, Bulgaria
Alberta Children's Hospital
Calgary, T2T 5C7, Canada
Queen Elizabeth Hospital
Charlottetown, PE C1A 8T5, Canada
University Of Alberta/Stollery Children's Hospital
Edmonton, AB T6G 2J3, Canada
Dalhousie University IWK Health Centre
Halifax, B3K 6R8, Canada
Mcmaster Children's Hospital
Hamilton, L8S 4J9, Canada
McGill University Health Centre Monteal Children's Hospital
Montreal, H3H 1P3, Canada
Sainte Justine Hospital
Montreal, H3T 1C5, Canada
Children's Hospital of Eastern Ontario
Ottawa, K1H 8L1, Canada
Centre Hospitalier de L'Universite Laval
Québec, G1V 4G2, Canada
Royal University Hospital
Saskatoon, STN 0W8, Canada
Children's And Women's Hospital of BC
Vancouver, V6H 3V4, Canada
Victoria General Hospital
Victoria, V8Z 6R5, Canada
Windsor Regional Hospital
Windsor, N8W 1L9, Canada
Manitoba Institute Of Child Health University of Manitoba
Winnipeg, R3E 3P4, Canada
Hospital San Jose
Independencia, 1196, Chile
Hospital Clinico de la Universidad de Chile
Independencia, Chile
Hospital Dr. Sotero Del Rio
Puente Alto, Chile
Hospital Dr. Feliz Buines Cerda
Quinta Normal, Chile
Hospital Clinico San Borja Arriaran
Santiago, Chile
Hospital Padre Hurtado
Santiago, Chile
Nemocnice CB
České Budějovice, 370 87, Czechia
FN Hradec Kralove Detska klinika
Hradec Králové, 500 05, Czechia
Nemocnice s poliklinikou v Moste
Most, 434 64, Czechia
Fakultni nemocnice
Olomouc, 775 20, Czechia
FNsP Ostrava
Ostrava, 708 52, Czechia
FN Plzen
Plzen-Bory, 305 99, Czechia
FN Plzen
Plzen-Lochotin, 304 60, Czechia
Vfn 1.Lf Uk
Prague, 128 00, Czechia
Fakultni Thomayerova nemocnice S poliklinkou
Prague, 140 59, Czechia
Ustav pro peci o matku a dite
Prague, 143 00, Czechia
FN Motol Novorozenecke oddeleni
Prague, 150 06, Czechia
Batova krajska nemocnice Zlin
Zlín, 762 75, Czechia
Paediatrisk Afdeling Herning Centralsygehus
Herning, 7400, Denmark
Hillerod Sygehus Helsevej 2
Hillerød, 3400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Sygehus Viborg
Viborg, 8800, Denmark
Service de Medecine Neonatale et de reanimation pediatrique
Amiens, 80054, France
CHU Angers
Angers, 49033, France
CHU de Besancon-Hopital Saint-Jacques
Besançon, 25030, France
CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B
Bordeaux, 33076, France
CH Chambery
Chambéry, BP1125, France
CHU Dijon
Dijon, 21079, France
Hopital Jeanne de Flandre
Lille, 59037, France
CHU Nord
Marseille, 13915, France
CHU Montpellier/Hoptial Arnaud de Villeneuve
Montpellier, 34000, France
CHU de Nantes/Hospital Mere-Enfant
Nantes, 44093, France
CHI Poissy/St Germain en Laye
Poissy, 78300, France
CHU Rennes/Hopital Sud
Rennes, 35203, France
CHU Rouen
Rouen, 76031, France
CH Pierre Haute
Strasbourg, 67098, France
CHU Toulouse-Hopital des Enfants
Toulouse, BP 3119, France
Centre Pediatrique Gatien de Clocheville
Tours, 37044, France
Ruhr-Uni St. Josef Hospital
Bochum, 44791, Germany
Klinikum Duisburg, Wedau Kliniken
Duisburg, 47055, Germany
Uni-Kinderklinik
Düsseldorf, 40225, Germany
Klinik fur Kinder und Jugendliche
Erlangen, 91054, Germany
Zentrum Klinische Studien/Universtatsklinikum Freiburg
Freiburg im Breisgau, 79110, Germany
Universtatsklinikum Gottingen
Göttingen, 37075, Germany
Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin
Halle, 06120, Germany
Stiftung Hannoversche
Hanover, 30173, Germany
Im Neuenheimer Feld 153
Heidelberg, 69120, Germany
Klinik und Poliklinik und Jugendiche der Universitat Leipzig
Leipzig, 04137, Germany
Universitatskinderlinik/Zentrum Fur klinische Studien
Mainz, 55101, Germany
Kinderklinik und Kinderpoliklinik
München, 80337, Germany
Stadtisches Krankenhaus Muchen-Harlaching
München, 81545, Germany
Evangelischisches Krankenhaus
Oberhausen, 46047, Germany
Klinikum Oldenberg
Oldenberg, 26133, Germany
Klinikum Rosenheim
Rosenheim, 83022, Germany
Asklepios Kinderklinik Sankt Augustin GmbH
Sankt Augustin, 53757, Germany
"P&A Kyriakou" Children's hospital
Athens, 11527, Greece
Aghia Sofia Children hospital
Athens, 11527, Greece
Aristotele University of Thessaloniki, General "AXEPA" Hospital
Thessaloniki, 54636, Greece
Hippokration Hospital, University of Thessaloniki
Thessaloniki, 54642, Greece
General hospital "Papageorgiou"
Thessaloniki, 56429, Greece
Semmelweis Univ.
Budapest, 1083, Hungary
Semmelweis University
Budapest, 1088, Hungary
Schopf-Merei Agost Hospital
Budapest, 1092, Hungary
Semmelweis Univ.
Budapest, 1094, Hungary
DEOEC Neonatology Division
Debrecen, 4012, Hungary
DEOEC, Dept. of Pediatry
Debrecen, 4012, Hungary
Petz Aladar Teaching Hospital
Győr, 9023, Hungary
Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza
Miskolc, 3501, Hungary
Josa Andras Hospital
Nyíregyháza, 4400, Hungary
University of Pecs
Pécs, 7623, Hungary
Univ. of Pecs
Pécs, 7624, Hungary
Csolnoky Ferenc Hospital
Veszprém, 8200, Hungary
Children's hospital, Landspitali University Hospital
Reykjavik, 101, Iceland
HaEmek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78306, Israel
Soroka Medical Center
Beersheba, 84101, Israel
Bnei Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 34362, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, 91120, Israel
Sapir Medical Center
Kfar Saba, 44281, Israel
Laniado Medical Center
Netanya, Israel
Schneider Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Sourasky Medical Center (Ichilov)
Tel Aviv, 64239, Israel
Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Poria Medical Center
Tiberias, Israel
Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"
Ancona, 60123, Italy
Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale
Bergamo, 24128, Italy
Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi
Bologna, 40139, Italy
Ospedale Generale di Bolzano
Bolzano, 39100, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, 12100, Italy
Azienda Ospedaliera Universitaria
Foggia, 71100, Italy
Azienda USL di Imola - Ospedale di Imola
Imola, 40026, Italy
Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"
Lecco, 23900, Italy
Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
Messina, 98100, Italy
Azienda Ospedaliera San Gerardo
Monza, 20052, Italy
Azienda Ospedaliera di Parma
Parma, 43100, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
Pisa, 56100, Italy
Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna
Torino, 10126, Italy
Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale
Udine, 33100, Italy
Middlemore Hospital
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Klinika Neonatologii AM w Białymstoku
Bialystok, 15-274, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka
Bydgoszcz, 85-168, Poland
Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka
Bydgoszcz, 85-667, Poland
Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy
Częstochowa, 42-200, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii
Gdansk, 80-952, Poland
Szpital Morski im. PCK, Oddział Dziecięcy
Gdynia, 81-519, Poland
Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie
Krakow, 31-501, Poland
Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii
Lodz, 91-738, Poland
Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie
Lublin, 20-093, Poland
Katedra i Klinika Neonatologii AM w Poznaniu
Poznan, 60-535, Poland
II Klinika Chorób Dzieci PAM, Samodzielny Publiczny
Szczecin, 71-252, Poland
Klinika Neonatologii AM w Warszawie
Warsaw, 00-315, Poland
Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, 04-736, Poland
Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.
Łęczna, 21-010, Poland
Pediatric City Hospital #13
Moscow, 103001, Russia
Morozovsky Pediatric City Hospital
Moscow, 117049, Russia
St. Petersburg City Outpatient Hospital #45
Saint Petersburg, 193312, Russia
Saint-Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100, Russia
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100, Russia
Pediatric City Hospital #1
Saint Petersburg, 198205, Russia
Smolensk State Medical Academy
Smolensk, 214018, Russia
Hospital Juan Canalejo
A Coruña, 15006, Spain
Hospital Clinic y Maternistat - Barcelona
Barcelona, 08036, Spain
Hospital Sant Joan de Déu (Barcelona)
Barcelona, 08950, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital de Cruces
Cruces, 48903, Spain
Hospital Josep Trueta
Girona, Spain
Hospital Virgen de las Nieves
Granada, 18014, Spain
Hospital de Donostia (San Sebastian)
Guipuzcoa, 20014, Spain
Hospital Materno Infantil deJaén
Jaén, 23007, Spain
Hospital General de Jerez
Jerez de la Frontera, 11407, Spain
Hospital Materno Infantil de Canarias
Las Palmas de Gran Canaria, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital La Paz- Madrid
Madrid, 28040, Spain
Hospital Severo Ochoa
Madrid, 28911, Spain
Hospital Materno Infantil/Neumología pediátrica
Málaga, 29011, Spain
Hospital Central de Asturias
Oviedo, 33006, Spain
Hospital Clinico de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Maternal Virgen del Rocío
Seville, 41013, Spain
Hospital Virgen Macarena
Seville, 41071, Spain
Hospital Joan XXIII
Tarragona, 43007, Spain
Hospital Universitario La Fe Maternidad
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Xeral-Cíes
Vigo, 36204, Spain
Mälarsjukhuset
Eskilstuna, 631 88, Sweden
The Queen Silvia Children's Hospital
Gothenburg, 41685, Sweden
Karolinska University Hospital Solna
Stockholm, 171 76, Sweden
Danderyds Sjukhus
Stockholm, 182 88, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi
Ankara, 06100, Turkey (Türkiye)
Ankara Üniversitesi
Ankara, Turkey (Türkiye)
Ege Üniversitesi Tıp Fakültesi
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylül Üniversitesi Tıp Fakültesi
Izmir, 35340, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, DG1 4AP, United Kingdom
Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Medway Maritime Hospital
Gillingham Kent, ME7 5NY, United Kingdom
Princess Anne Hospital
Hants, SO16 5YA, United Kingdom
Claredon Wing, Leeds General Infirmary
Leeds, LS2 9NS, United Kingdom
St James' University Hospital
Leeds, LS9 7TF, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Queen's Medical Centre Nottingham University Hospital
Nottingham, NG7 2UH, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Royal Hampshire County Hospital
Winchester, SO22 5DG, United Kingdom
Related Publications (1)
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.
PMID: 20008423RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- M. Pamela Griffin, Sr. Director, Clinical Development
- Organization
- MedImmune
Study Officials
- STUDY DIRECTOR
M Pamela Griffin, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 12, 2005
Study Start
November 1, 2004
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
August 28, 2013
Results First Posted
August 28, 2013
Record last verified: 2013-06