Clinical trial NCT00129766: Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus (RSV)
motavizumab
palivizumab
Synagis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 6635
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of RSV Hospitalization (Includes Deaths by RSV)
timeFrame: Days 0 - 150
measure: Number of Participants Reporting Any Adverse Events (AEs)
timeFrame: Days 0 - 150
measure: Number of Participants Reporting Any Related AEs
timeFrame: Days 0 - 150
measure: Number of Participants Reporting Any Serious Adverse Events (SAEs)
timeFrame: Days 0 - 150
measure: Number of Participants Reporting Any Related SAEs
timeFrame: Days 0 - 150
measure: Number of Participants Reporting AEs by Highest Severity Grade
timeFrame: Days 0 - 150
measure: Number of Participants Who Discontinued Study Drug Due to AEs
timeFrame: Days 0 - 150
measure: Number of Participants Who Died
timeFrame: Days 0 - 150
measure: Number of Participants Reporting Changes in Vital Signs From Baseline
timeFrame: Days 0 - 150
Secondary outcomes:
measure: The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
timeFrame: Day 0 - 150
measure: The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
timeFrame: Days 0 - 150
measure: The Incidence of Medically-attended Otitis Media (OM) Infections
timeFrame: Days 0 - 150
measure: The Frequency of Prescribed Antibiotics for Medically-attended LRI
timeFrame: Days 0 - 150
measure: The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
timeFrame: Days 0 - 150
measure: The Number of Participants With Anti-motavizumab Antibodies
timeFrame: Day 0 - 120
measure: The Serum Concentrations of Motavizumab at Day 0
timeFrame: Day 0
measure: The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
timeFrame: 30 days post Dose 1
measure: The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
timeFrame: 30 days post Dose 2
measure: The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
timeFrame: 30 days post Dose 3
measure: The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
timeFrame: 30 days post Dose 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Pike Road
country: United States
facility: Alabama Neonatal Medicine OC
state: Alabama
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic, PA
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic Of Jonesboro, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Children's Clinic, PA
state: Arkansas
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Health Care Plan
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: Children's Hospital San Diego
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Stamford
country: United States
facility: Pediatric Pulmonology, LLC
state: Connecticut
city: Wilmington
country: United States
facility: A. I. Dupont Hospital For Children
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands Hospital At The University Of Florida
state: Florida
city: Jacksonville
country: United States
facility: The Nemours Children's Clinic
state: Florida
city: Miami
country: United States
facility: University Of Miami Medical Center
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Clinic Biomedical Research
state: Florida
city: Tampa
country: United States
facility: Univ. S. Florida Pediatrics Ambulatory Care Center
state: Florida
city: Atlanta
country: United States
facility: Emory University School Of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Georgia Pediatric Pulmonology Associates
state: Georgia
city: Augusta
country: United States
facility: The Medical College Of Georgia
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Woman and Children
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Cook
country: United States
facility: Advocate Hope Children's Hospital
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana State University MidCity Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Hospital for Children
state: Louisiana
city: Baltimore
country: United States
facility: University Of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Mott Children's Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital Of Michigan
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: DeVos Children's Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic
state: Minnesota
city: St. Paul
country: United States
facility: Children's Healthcare D.B.A. Hospitals & Clinics
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center Pediatric
state: Nebraska
city: Las Vegas
country: United States
facility: Children's Lung Specialist, Ltd
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Medical School
state: New Hampshire
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: The Brooklyn Hospital Center
state: New York
city: Buffalo
country: United States
facility: Women & Children's Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Poughkeepsie
country: United States
facility: The Children's Medical Group
state: New York
city: Rochester
country: United States
facility: University Of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: University Hospital State University of New York at Stony Brook Department of Pediatrics
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital NICU
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University School of Medicine
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Pediatric Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Akron
country: United States
facility: Children's Hospital Medical Center Of Akron
state: Ohio
city: Boardman
country: United States
facility: Beehly Medical Park Women's and Children's Pav.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Col. of Med.
state: Ohio
city: Cleveland
country: United States
facility: Metro Health Medical Center
state: Ohio
city: Columbus
country: United States
facility: Pediatric Clinical Trials International, Inc.
state: Ohio
city: Dayton
country: United States
facility: Children's Medical Center
state: Ohio
city: Mahaning
country: United States
facility: Tod Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Children's Hospital Of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Saint Francis Hospital EOPC
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center- JW Children's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital Of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson-duPont Children's Health Program
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital University of South Dakota Medical Center
state: South Dakota
city: Memphis
country: United States
facility: Lebonheur Children's Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Univ. Of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University Of Texas Houston Medical School
state: Texas
city: Lubbock
country: United States
facility: Texas Tech Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: University Of Texas Health Science Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Hospital
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Huntington
country: United States
facility: University Physicians
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Joseph's Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital, Inc
state: Wisconsin
city: Wauwatosa
country: United States
facility: Children's Corporate Center
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Peiade Interzonal General de Augodos
city: Buenos Aires
country: Argentina
facility: Hospital General De Ninos Pedro De Elizalde
city: Capital Federal
country: Argentina
facility: Sanatorio Trinidad
city: Cordoba
country: Argentina
facility: Hospital Materno Neonatal
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: New Lambton
country: Australia
facility: John Hunter Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Children's Hospital (Brisbane)
state: Queensland
city: Kippa-Ring
country: Australia
facility: Peninsula Clinical Research Centre
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Mothers Hospital Raymond Terrace
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Parkville
country: Australia
facility: Royal Children's Hospital (Melbourne)
state: Victoria
city: Subiaco
country: Australia
facility: Princess Margaret Children's Hospital
state: Western Australia
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
city: Graz
country: Austria
facility: Universitatsklinik fur Kinder und Jugenheilkunde, Graz
city: Tulln
country: Austria
facility: LandesKrankenHaus Tulln, Kinderabteilung
city: Wien
country: Austria
facility: Allgemeines KrankenHaus Universitatsklinkiken Wein
city: Wien
country: Austria
facility: SMZ-Ost Donauspital Wien
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro-Puccamp
city: Curitiba
country: Brazil
facility: Mernidade Nossa Senhora De Fatima
city: Curitiba
country: Brazil
facility: Hospital De Clinicas Da UFPR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina
city: Sao Paulo
country: Brazil
facility: Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital e Maternidade Santa Marina
city: Sao Paulo
country: Brazil
facility: Hospital Universitario de Universidade de Sao Paulo
city: Pleven
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment "Pleven"
city: Plovdiv
country: Bulgaria
facility: University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic
city: Plovdiv
country: Bulgaria
facility: University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics
city: Plovdiv
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment - Plovdiv
city: Rousse
country: Bulgaria
facility: Regional Hospital of Pulmonary Diseases
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pediatric Diseases
city: Varna
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment "St. Marina"
city: Calgary
country: Canada
facility: Alberta Children's Hospital
city: Charlottetown
country: Canada
facility: Queen Elizabeth Hospital
city: Edmonton
country: Canada
facility: University Of Alberta/Stollery Children's Hospital
city: Halifax
country: Canada
facility: Dalhousie University IWK Health Centre
city: Hamilton
country: Canada
facility: Mcmaster Children's Hospital
city: Montreal
country: Canada
facility: McGill University Health Centre Monteal Children's Hospital
city: Montreal
country: Canada
facility: Sainte Justine Hospital
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
city: Quebec City
country: Canada
facility: Centre Hospitalier de L'Universite Laval
city: Saskatoon
country: Canada
facility: Royal University Hospital
city: Vancouver
country: Canada
facility: Children's And Women's Hospital of BC
city: Victoria
country: Canada
facility: Victoria General Hospital
city: Windsor
country: Canada
facility: Windsor Regional Hospital
city: Winnipeg
country: Canada
facility: Manitoba Institute Of Child Health University of Manitoba
city: Independencia
country: Chile
facility: Hospital San Jose
city: Independencia
country: Chile
facility: Hospital Clinico de la Universidad de Chile
city: Puente Alto
country: Chile
facility: Hospital Dr. Sotero Del Rio
city: Quinta Normal
country: Chile
facility: Hospital Dr. Feliz Buines Cerda
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriaran
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Ceske Budejovice
country: Czech Republic
facility: Nemocnice CB
city: Hradec Kralove
country: Czech Republic
facility: FN Hradec Kralove Detska klinika
city: Most
country: Czech Republic
facility: Nemocnice s poliklinikou v Moste
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice
city: Ostrava
country: Czech Republic
facility: FNsP Ostrava
city: Plzen-Bory
country: Czech Republic
facility: FN Plzen
city: Plzen-Lochotin
country: Czech Republic
facility: FN Plzen
city: Praha 2
country: Czech Republic
facility: Vfn 1.Lf Uk
city: Praha 4
country: Czech Republic
facility: Fakultni Thomayerova nemocnice S poliklinkou
city: Praha 4
country: Czech Republic
facility: Ustav pro peci o matku a dite
city: Praha 5
country: Czech Republic
facility: FN Motol Novorozenecke oddeleni
city: Zlin
country: Czech Republic
facility: Batova krajska nemocnice Zlin
city: Herning
country: Denmark
facility: Paediatrisk Afdeling Herning Centralsygehus
city: Hillerod
country: Denmark
facility: Hillerod Sygehus Helsevej 2
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Viborg
country: Denmark
facility: Sygehus Viborg
city: Amiens Cedex 1
country: France
facility: Service de Medecine Neonatale et de reanimation pediatrique
city: Angers
country: France
facility: CHU Angers
city: Besancon
country: France
facility: CHU de Besancon-Hopital Saint-Jacques
city: Bordeaux
country: France
facility: CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B
city: Chambery
country: France
facility: CH Chambery
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: Hopital Jeanne de Flandre
city: Marseille
country: France
facility: CHU Nord
city: Montpellier
country: France
facility: CHU Montpellier/Hoptial Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU de Nantes/Hospital Mere-Enfant
city: Poissy Cedex
country: France
facility: CHI Poissy/St Germain en Laye
city: Rennes Cedex
country: France
facility: CHU Rennes/Hopital Sud
city: Rouen Cedex
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: CH Pierre Haute
city: Toulouse Cedex 9
country: France
facility: CHU Toulouse-Hopital des Enfants
city: Tours Cedex
country: France
facility: Centre Pediatrique Gatien de Clocheville
city: Bochum
country: Germany
facility: Ruhr-Uni St. Josef Hospital
city: Duisburg
country: Germany
facility: Klinikum Duisburg, Wedau Kliniken
city: Dusseldorf
country: Germany
facility: Uni-Kinderklinik
city: Erlangen
country: Germany
facility: Klinik fur Kinder und Jugendliche
city: Freiburg
country: Germany
facility: Zentrum Klinische Studien/Universtatsklinikum Freiburg
city: Gottingen
country: Germany
facility: Universtatsklinikum Gottingen
city: Halle
country: Germany
facility: Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin
city: Hannover
country: Germany
facility: Stiftung Hannoversche
city: Heidelberg
country: Germany
facility: Im Neuenheimer Feld 153
city: Leipzig
country: Germany
facility: Klinik und Poliklinik und Jugendiche der Universitat Leipzig
city: Mainz
country: Germany
facility: Universitatskinderlinik/Zentrum Fur klinische Studien
city: Muenchen
country: Germany
facility: Kinderklinik und Kinderpoliklinik
city: Munchen
country: Germany
facility: Stadtisches Krankenhaus Muchen-Harlaching
city: Oberhausen
country: Germany
facility: Evangelischisches Krankenhaus
city: Oldenberg
country: Germany
facility: Klinikum Oldenberg
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Sankt Augustin
country: Germany
facility: Asklepios Kinderklinik Sankt Augustin GmbH
city: Athens
country: Greece
facility: "P&A Kyriakou" Children's hospital
city: Athens
country: Greece
facility: Aghia Sofia Children hospital
city: Thessaloniki
country: Greece
facility: Aristotele University of Thessaloniki, General "AXEPA" Hospital
city: Thessaloniki
country: Greece
facility: Hippokration Hospital, University of Thessaloniki
city: Thessaloniki
country: Greece
facility: General hospital "Papageorgiou"
city: Budapest
country: Hungary
facility: Semmelweis Univ.
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Schopf-Merei Agost Hospital
city: Budapest
country: Hungary
facility: Semmelweis Univ.
city: Debrecen
country: Hungary
facility: DEOEC Neonatology Division
city: Debrecen
country: Hungary
facility: DEOEC, Dept. of Pediatry
city: Gyor
country: Hungary
facility: Petz Aladar Teaching Hospital
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Hospital
city: Pecs
country: Hungary
facility: University of Pecs
city: Pecs
country: Hungary
facility: Univ. of Pecs
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Hospital
city: Reykjavik
country: Iceland
facility: Children's hospital, Landspitali University Hospital
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
city: Kfar-Saba
country: Israel
facility: Sapir Medical Center
city: Natanya
country: Israel
facility: Laniado Medical Center
city: Petach Tikva
country: Israel
facility: Schneider Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center (Ichilov)
city: Tel-Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Tiberia
country: Israel
facility: Poria Medical Center
city: Ancona
country: Italy
facility: Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale
city: Bologna
country: Italy
facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi
city: Bolzano
country: Italy
facility: Ospedale Generale di Bolzano
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Imola
country: Italy
facility: Azienda USL di Imola - Ospedale di Imola
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Parma
country: Italy
facility: Azienda Ospedaliera di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna
city: Udine
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
city: Białystok
country: Poland
facility: Klinika Neonatologii AM w Białymstoku
city: Bydgoszcz
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka
city: Bydgoszcz
country: Poland
facility: Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka
city: Częstochowa
country: Poland
facility: Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy
city: Gdańsk
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK, Oddział Dziecięcy
city: Krakow
country: Poland
facility: Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie
city: Leczna
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.
city: Lublin
country: Poland
facility: Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie
city: Poznań
country: Poland
facility: Katedra i Klinika Neonatologii AM w Poznaniu
city: Szczecin
country: Poland
facility: II Klinika Chorób Dzieci PAM, Samodzielny Publiczny
city: Warsaw
country: Poland
facility: Klinika Neonatologii AM w Warszawie
city: Warszawa
country: Poland
facility: Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka
city: Łódź
country: Poland
facility: Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii
city: Łódź
country: Poland
facility: Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki
city: Moscow
country: Russian Federation
facility: Pediatric City Hospital #13
city: Moscow
country: Russian Federation
facility: Morozovsky Pediatric City Hospital
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg City Outpatient Hospital #45
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg State Pediatric Medical Academy
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Pediatric Medical Academy
city: St. Petersburg
country: Russian Federation
facility: Pediatric City Hospital #1
city: Barcelona
country: Spain
facility: Hospital Clinic y Maternistat - Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu (Barcelona)
city: Cruces
country: Spain
facility: Hospital de Cruces
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Gerona
country: Spain
facility: Hospital Josep Trueta
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Guipuzcoa
country: Spain
facility: Hospital de Donostia (San Sebastian)
city: Jaén
country: Spain
facility: Hospital Materno Infantil deJaén
city: Jerez
country: Spain
facility: Hospital General de Jerez
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Materno Infantil de Canarias
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz- Madrid
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Malaga
country: Spain
facility: Hospital Materno Infantil/Neumología pediátrica
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Clinico de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Maternal Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario La Fe Maternidad
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Vigo
country: Spain
facility: Hospital Xeral-Cíes
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Goteborg
country: Sweden
facility: The Queen Silvia Children's Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi
city: Ankara
country: Turkey
facility: Ankara Üniversitesi
city: Izmir
country: Turkey
facility: Ege Üniversitesi Tıp Fakültesi
city: Izmir
country: Turkey
facility: Dokuz Eylül Üniversitesi Tıp Fakültesi
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Dumfries
country: United Kingdom
facility: Dumfries and Galloway Royal Infirmary
city: Dundee
country: United Kingdom
facility: Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital
city: Gillingham Kent
country: United Kingdom
facility: Medway Maritime Hospital
city: Hants
country: United Kingdom
facility: Princess Anne Hospital
city: Leeds
country: United Kingdom
facility: Claredon Wing, Leeds General Infirmary
city: Leeds
country: United Kingdom
facility: St James' University Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre Nottingham University Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
Study officials:
affiliation: MedImmune LLC
name: M Pamela Griffin, MD
role: STUDY_DIRECTOR
References:
citation: 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.