Back to resultsStudy of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
motavizumab (MEDI-524)
palivizumab
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus (RSV), motavizumab, palivizumab, Synagis
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
Sites / Locations
- University Of Alabama At Birmingham
- Alabama Neonatal Medicine OC
- Maricopa Medical Center
- Central Arkansas Pediatric Clinic, PA
- The Children's Clinic Of Jonesboro, P.A.
- Arkansas Children's Hospital Research Institute
- Arkansas Pediatric Clinic
- Little Rock Children's Clinic, PA
- Miller Children's Hospital
- Kaiser Permanente Los Angeles
- Children's Hospital of Oakland
- Kaiser Permanente Health Care Plan
- Children's Hospital of Orange County
- University of California
- Children's Hospital San Diego
- California Pacific Medical Center
- Santa Clara Valley Medical Center
- Children's Hospital
- Connecticut Children's Medical Center
- Pediatric Pulmonology, LLC
- A. I. Dupont Hospital For Children
- Georgetown University Medical Center
- Children's National Medical Center
- Shands Hospital At The University Of Florida
- The Nemours Children's Clinic
- University Of Miami Medical Center
- Nemours Children's Clinic Biomedical Research
- Univ. S. Florida Pediatrics Ambulatory Care Center
- Emory University School Of Medicine
- Georgia Pediatric Pulmonology Associates
- The Medical College Of Georgia
- Kapiolani Medical Center for Woman and Children
- University of Illinois at Chicago
- Children's Memorial Hospital
- Advocate Hope Children's Hospital
- Lutheran General Children's Hospital
- James Whitcomb Riley Hospital for Children
- Memorial Hospital of South Bend
- University of Louisville
- Louisiana State University MidCity Clinic
- Tulane Hospital for Children
- University Of Maryland School of Medicine
- Tufts-New England Medical Center
- Boston Medical Center
- Baystate Medical Center
- University of Michigan Mott Children's Hospital
- Children's Hospital Of Michigan
- St. John Hospital & Medical Center
- DeVos Children's Hospital
- St. Mary's Duluth Clinic
- Children's Healthcare D.B.A. Hospitals & Clinics
- Children's Mercy Hospital
- Research Medical Center
- University of Nebraska Medical Center Pediatric
- Children's Lung Specialist, Ltd
- Dartmouth Medical School
- Saint Barnabas Medical Center
- New Jersey Medical School
- Albany Medical Center
- Bronx-Lebanon Hospital Center
- Jacobi Medical Center
- Montefiore Medical Center
- The Brooklyn Hospital Center
- Women & Children's Hospital
- Winthrop University Hospital
- Schneider Children's Hospital
- The Children's Medical Group
- University Of Rochester Medical Center
- University Hospital State University of New York at Stony Brook Department of Pediatrics
- Crouse Hospital NICU
- SUNY Upstate Medical University
- University of North Carolina-School of Medicine
- Carolinas Medical Center
- Duke University Medical Center
- East Carolina University School of Medicine
- Raleigh Pediatric Associates
- Wake Forest University School of Medicine
- Children's Hospital Medical Center Of Akron
- Beehly Medical Park Women's and Children's Pav.
- University of Cincinnati Col. of Med.
- Metro Health Medical Center
- Pediatric Clinical Trials International, Inc.
- Children's Medical Center
- Tod Children's Hospital
- Toledo Children's Hospital
- St. Vincent Medical Center
- Children's Hospital Of Oklahoma
- Saint Francis Hospital EOPC
- Oregon Health Sciences University
- Lehigh Valley Hospital
- St. Luke's Hospital
- Bryn Mawr Hospital
- Geisinger Medical Center- JW Children's Hospital
- The Children's Hospital Of Philadelphia
- Jefferson-duPont Children's Health Program
- Pennsylvania Hospital
- Allegheny General Hospital
- Children's Hospital of Pittsburgh
- Rhode Island Hospital
- MUSC
- Sioux Valley Hospital University of South Dakota Medical Center
- Lebonheur Children's Medical Center
- Vanderbilt University Medical Center
- Driscoll Children's Hospital
- Baylor University Medical Center
- Univ. Of Texas Southwestern Medical Center
- Texas Children's Hospital
- University Of Texas Houston Medical School
- Texas Tech Health Sciences Center
- University Of Texas Health Science Center
- Scott & White Memorial Hospital
- Primary Children's Medical Center
- University of Virginia Hospital
- VCU Medical Center
- University Physicians
- West Virginia University
- Marshfield Clinic
- St. Joseph's Hospital
- Waukesha Memorial Hospital, Inc
- Children's Corporate Center
- Hospital Peiade Interzonal General de Augodos
- Hospital General De Ninos Pedro De Elizalde
- Sanatorio Trinidad
- Hospital Materno Neonatal
- The Canberra Hospital
- John Hunter Children's Hospital
- Westmead Hospital
- Royal Children's Hospital (Brisbane)
- Peninsula Clinical Research Centre
- Mater Mothers Hospital Raymond Terrace
- Royal Hobart Hospital
- Royal Children's Hospital (Melbourne)
- Princess Margaret Children's Hospital
- Women's and Children's Hospital
- Universitatsklinik fur Kinder und Jugenheilkunde, Graz
- LandesKrankenHaus Tulln, Kinderabteilung
- Allgemeines KrankenHaus Universitatsklinkiken Wein
- SMZ-Ost Donauspital Wien
- Hospital e Maternidade Celso Pierro-Puccamp
- Mernidade Nossa Senhora De Fatima
- Hospital De Clinicas Da UFPR
- Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo
- Hospital Das Clinicas Da Faculdade De Medicina
- Santa Casa de Misericordia de Sao Paulo
- Hospital e Maternidade Santa Marina
- Hospital Universitario de Universidade de Sao Paulo
- Multifunctional Hospital for Active Treatment "Pleven"
- University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic
- University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics
- Multifunctional Hospital for Active Treatment - Plovdiv
- Regional Hospital of Pulmonary Diseases
- Specialized Hospital for Active Treatment of Cardio-vascular Diseases
- Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"
- Specialized Hospital for Active Treatment of Pediatric Diseases
- Multifunctional Hospital for Active Treatment "St. Marina"
- Alberta Children's Hospital
- Queen Elizabeth Hospital
- University Of Alberta/Stollery Children's Hospital
- Dalhousie University IWK Health Centre
- Mcmaster Children's Hospital
- McGill University Health Centre Monteal Children's Hospital
- Sainte Justine Hospital
- Children's Hospital of Eastern Ontario
- Centre Hospitalier de L'Universite Laval
- Royal University Hospital
- Children's And Women's Hospital of BC
- Victoria General Hospital
- Windsor Regional Hospital
- Manitoba Institute Of Child Health University of Manitoba
- Hospital San Jose
- Hospital Clinico de la Universidad de Chile
- Hospital Dr. Sotero Del Rio
- Hospital Dr. Feliz Buines Cerda
- Hospital Clinico San Borja Arriaran
- Hospital Padre Hurtado
- Nemocnice CB
- FN Hradec Kralove Detska klinika
- Nemocnice s poliklinikou v Moste
- Fakultni nemocnice
- FNsP Ostrava
- FN Plzen
- FN Plzen
- Vfn 1.Lf Uk
- Fakultni Thomayerova nemocnice S poliklinkou
- Ustav pro peci o matku a dite
- FN Motol Novorozenecke oddeleni
- Batova krajska nemocnice Zlin
- Paediatrisk Afdeling Herning Centralsygehus
- Hillerod Sygehus Helsevej 2
- Hvidovre Hospital
- Sygehus Viborg
- Service de Medecine Neonatale et de reanimation pediatrique
- CHU Angers
- CHU de Besancon-Hopital Saint-Jacques
- CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B
- CH Chambery
- CHU Dijon
- Hopital Jeanne de Flandre
- CHU Nord
- CHU Montpellier/Hoptial Arnaud de Villeneuve
- CHU de Nantes/Hospital Mere-Enfant
- CHI Poissy/St Germain en Laye
- CHU Rennes/Hopital Sud
- CHU Rouen
- CH Pierre Haute
- CHU Toulouse-Hopital des Enfants
- Centre Pediatrique Gatien de Clocheville
- Ruhr-Uni St. Josef Hospital
- Klinikum Duisburg, Wedau Kliniken
- Uni-Kinderklinik
- Klinik fur Kinder und Jugendliche
- Zentrum Klinische Studien/Universtatsklinikum Freiburg
- Universtatsklinikum Gottingen
- Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin
- Stiftung Hannoversche
- Im Neuenheimer Feld 153
- Klinik und Poliklinik und Jugendiche der Universitat Leipzig
- Universitatskinderlinik/Zentrum Fur klinische Studien
- Kinderklinik und Kinderpoliklinik
- Stadtisches Krankenhaus Muchen-Harlaching
- Evangelischisches Krankenhaus
- Klinikum Oldenberg
- Klinikum Rosenheim
- Asklepios Kinderklinik Sankt Augustin GmbH
- "P&A Kyriakou" Children's hospital
- Aghia Sofia Children hospital
- Aristotele University of Thessaloniki, General "AXEPA" Hospital
- Hippokration Hospital, University of Thessaloniki
- General hospital "Papageorgiou"
- Semmelweis Univ.
- Semmelweis University
- Schopf-Merei Agost Hospital
- Semmelweis Univ.
- DEOEC Neonatology Division
- DEOEC, Dept. of Pediatry
- Petz Aladar Teaching Hospital
- Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza
- Josa Andras Hospital
- University of Pecs
- Univ. of Pecs
- Csolnoky Ferenc Hospital
- Children's hospital, Landspitali University Hospital
- HaEmek Medical Center
- Barzilai Medical Center
- Soroka Medical Center
- Bnei Zion Medical Center
- Rambam Medical Center
- Carmel Medical Center
- Wolfson Medical Center
- Shaare Zedek Medical Center
- Hadassah Ein-Kerem Medical Center
- Sapir Medical Center
- Laniado Medical Center
- Schneider Medical Center
- Kaplan Medical Center
- Sourasky Medical Center (Ichilov)
- Chaim Sheba Medical Center
- Poria Medical Center
- Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"
- Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale
- Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi
- Ospedale Generale di Bolzano
- Spedali Civili di Brescia
- Azienda Ospedaliera S. Croce e Carle
- Azienda Ospedaliera Universitaria
- Azienda USL di Imola - Ospedale di Imola
- Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"
- Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
- Azienda Ospedaliera San Gerardo
- Azienda Ospedaliera di Parma
- Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
- Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna
- Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale
- Middlemore Hospital
- Dunedin Hospital
- Waikato Hospital
- Palmerston North Hospital
- Klinika Neonatologii AM w Białymstoku
- Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka
- Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka
- Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy
- Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii
- Szpital Morski im. PCK, Oddział Dziecięcy
- Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie
- Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.
- Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie
- Katedra i Klinika Neonatologii AM w Poznaniu
- II Klinika Chorób Dzieci PAM, Samodzielny Publiczny
- Klinika Neonatologii AM w Warszawie
- Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka
- Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii
- Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki
- Pediatric City Hospital #13
- Morozovsky Pediatric City Hospital
- Smolensk State Medical Academy
- St. Petersburg City Outpatient Hospital #45
- Saint-Petersburg State Pediatric Medical Academy
- St. Petersburg State Pediatric Medical Academy
- Pediatric City Hospital #1
- Hospital Clinic y Maternistat - Barcelona
- Hospital Sant Joan de Déu (Barcelona)
- Hospital de Cruces
- Hospital Reina Sofia
- Hospital Josep Trueta
- Hospital Virgen de las Nieves
- Hospital de Donostia (San Sebastian)
- Hospital Materno Infantil deJaén
- Hospital General de Jerez
- Hospital Juan Canalejo
- Hospital Materno Infantil de Canarias
- Hospital Clínico San Carlos
- Hospital La Paz- Madrid
- Hospital Severo Ochoa
- Hospital Materno Infantil/Neumología pediátrica
- Hospital Central de Asturias
- Hospital Clinico de Salamanca
- Hospital Universitario de Canarias
- Hospital Clinico Universitario de Santiago
- Hospital Maternal Virgen del Rocío
- Hospital Virgen Macarena
- Hospital Joan XXIII
- Hospital Universitario La Fe Maternidad
- Hospital Clinico Universitario de Valencia
- Hospital Xeral-Cíes
- Mälarsjukhuset
- The Queen Silvia Children's Hospital
- Karolinska University Hospital Solna
- Danderyds Sjukhus
- Uppsala University Hospital
- Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi
- Ankara Üniversitesi
- Ege Üniversitesi Tıp Fakültesi
- Dokuz Eylül Üniversitesi Tıp Fakültesi
- Birmingham Heartlands Hospital
- Dumfries and Galloway Royal Infirmary
- Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital
- Medway Maritime Hospital
- Princess Anne Hospital
- Claredon Wing, Leeds General Infirmary
- St James' University Hospital
- James Cook University Hospital
- Queen's Medical Centre Nottingham University Hospital
- Sheffield Children's Hospital
- Royal Hampshire County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
palivizumab
motavizumab (MEDI-524)
Arm Description
15 mg/kg administered intramuscularly for 5 monthly doses
15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
Outcomes
Primary Outcome Measures
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).
Number of Participants Reporting Any Adverse Events (AEs)
Number of participants reporting one or more AEs
Number of Participants Reporting Any Related AEs
Number of participants reporting one or more AEs considered related to study drug by the investigator
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Number of participants reporting one or more SAEs
Number of Participants Reporting Any Related SAEs
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Number of Participants Reporting AEs by Highest Severity Grade
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Number of Participants Who Discontinued Study Drug Due to AEs
Number of Participants Who Died
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
Secondary Outcome Measures
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.
The Incidence of Medically-attended Otitis Media (OM) Infections
Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.
The Frequency of Prescribed Antibiotics for Medically-attended LRI
The average number of presciptions per event per subject was summarized for each treatment group.
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
The average number of presciptions per event per subject was summarized for each treatment group.
The Number of Participants With Anti-motavizumab Antibodies
Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.
The Serum Concentrations of Motavizumab at Day 0
Mean serum concentrations of motavizumab at Day 0
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
Mean serum concentrations of motavizumab at 30 days post Dose 1
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
Mean serum concentrations of motavizumab at 30 days post Dose 2
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
Mean serum concentrations of motavizumab at 30 days post Dose 3
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
Mean serum concentrations of motavizumab at 30 days post Dose 4
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00129766
Brief Title
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
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory Syncytial Virus (RSV), motavizumab, palivizumab, Synagis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6635 (Actual)
8. Arms, Groups, and Interventions
Arm Title
palivizumab
Arm Type
Active Comparator
Arm Description
15 mg/kg administered intramuscularly for 5 monthly doses
Arm Title
motavizumab (MEDI-524)
Arm Type
Experimental
Arm Description
15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses
Intervention Type
Biological
Intervention Name(s)
motavizumab (MEDI-524)
Other Intervention Name(s)
MEDI-524
Intervention Description
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Intervention Type
Biological
Intervention Name(s)
palivizumab
Other Intervention Name(s)
Synagis
Intervention Description
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Primary Outcome Measure Information:
Title
Incidence of RSV Hospitalization (Includes Deaths by RSV)
Description
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).
Time Frame
Days 0 - 150
Title
Number of Participants Reporting Any Adverse Events (AEs)
Description
Number of participants reporting one or more AEs
Time Frame
Days 0 - 150
Title
Number of Participants Reporting Any Related AEs
Description
Number of participants reporting one or more AEs considered related to study drug by the investigator
Time Frame
Days 0 - 150
Title
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Description
Number of participants reporting one or more SAEs
Time Frame
Days 0 - 150
Title
Number of Participants Reporting Any Related SAEs
Description
Number of participants reporting one or more SAEs considered related to study drug by the investigator
Time Frame
Days 0 - 150
Title
Number of Participants Reporting AEs by Highest Severity Grade
Description
Adverse events events were graded by severity; Level 1, 2, 3, or 4
Time Frame
Days 0 - 150
Title
Number of Participants Who Discontinued Study Drug Due to AEs
Time Frame
Days 0 - 150
Title
Number of Participants Who Died
Time Frame
Days 0 - 150
Title
Number of Participants Reporting Changes in Vital Signs From Baseline
Description
Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs
Time Frame
Days 0 - 150
Secondary Outcome Measure Information:
Title
The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)
Description
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.
Time Frame
Day 0 - 150
Title
The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups
Description
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.
Time Frame
Days 0 - 150
Title
The Incidence of Medically-attended Otitis Media (OM) Infections
Description
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.
Time Frame
Days 0 - 150
Title
The Frequency of Prescribed Antibiotics for Medically-attended LRI
Description
The average number of presciptions per event per subject was summarized for each treatment group.
Time Frame
Days 0 - 150
Title
The Frequency of Prescribed Antibiotics for Medically-attended OM Infections
Description
The average number of presciptions per event per subject was summarized for each treatment group.
Time Frame
Days 0 - 150
Title
The Number of Participants With Anti-motavizumab Antibodies
Description
Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.
Time Frame
Day 0 - 120
Title
The Serum Concentrations of Motavizumab at Day 0
Description
Mean serum concentrations of motavizumab at Day 0
Time Frame
Day 0
Title
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1
Description
Mean serum concentrations of motavizumab at 30 days post Dose 1
Time Frame
30 days post Dose 1
Title
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2
Description
Mean serum concentrations of motavizumab at 30 days post Dose 2
Time Frame
30 days post Dose 2
Title
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3
Description
Mean serum concentrations of motavizumab at 30 days post Dose 3
Time Frame
30 days post Dose 3
Title
The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4
Description
Mean serum concentrations of motavizumab at 30 days post Dose 4
Time Frame
30 days post Dose 4
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Pamela Griffin, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alabama Neonatal Medicine OC
City
Pike Road
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Central Arkansas Pediatric Clinic, PA
City
Benton
State/Province
Arkansas
ZIP/Postal Code
72015
Country
United States
Facility Name
The Children's Clinic Of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Arkansas Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Little Rock Children's Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Kaiser Permanente Health Care Plan
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95728
Country
United States
Facility Name
Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Pediatric Pulmonology, LLC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06920
Country
United States
Facility Name
A. I. Dupont Hospital For Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shands Hospital At The University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
The Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University Of Miami Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nemours Children's Clinic Biomedical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Univ. S. Florida Pediatrics Ambulatory Care Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University School Of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Pediatric Pulmonology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The Medical College Of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Kapiolani Medical Center for Woman and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Advocate Hope Children's Hospital
City
Cook
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Lutheran General Children's Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
James Whitcomb Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University MidCity Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Tulane Hospital for Children
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University Of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Hospital Of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
St. Mary's Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Children's Healthcare D.B.A. Hospitals & Clinics
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
University of Nebraska Medical Center Pediatric
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Children's Lung Specialist, Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89107
Country
United States
Facility Name
Dartmouth Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx-Lebanon Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
The Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Women & Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The Children's Medical Group
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
University Of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University Hospital State University of New York at Stony Brook Department of Pediatrics
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Crouse Hospital NICU
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina-School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Raleigh Pediatric Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Children's Hospital Medical Center Of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Beehly Medical Park Women's and Children's Pav.
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
University of Cincinnati Col. of Med.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Metro Health Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Pediatric Clinical Trials International, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Tod Children's Hospital
City
Mahaning
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Children's Hospital Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5066
Country
United States
Facility Name
Saint Francis Hospital EOPC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Geisinger Medical Center- JW Children's Hospital
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
The Children's Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson-duPont Children's Health Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sioux Valley Hospital University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
Lebonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Univ. Of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Texas Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
University Of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
85113
Country
United States
Facility Name
University of Virginia Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University Physicians
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
St. Joseph's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Facility Name
Waukesha Memorial Hospital, Inc
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Children's Corporate Center
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Peiade Interzonal General de Augodos
City
Buenos Aires
ZIP/Postal Code
B1754FWE
Country
Argentina
Facility Name
Hospital General De Ninos Pedro De Elizalde
City
Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina
Facility Name
Sanatorio Trinidad
City
Capital Federal
ZIP/Postal Code
C145AIN
Country
Argentina
Facility Name
Hospital Materno Neonatal
City
Cordoba
ZIP/Postal Code
C5000BJH
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
John Hunter Children's Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital (Brisbane)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Peninsula Clinical Research Centre
City
Kippa-Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Mater Mothers Hospital Raymond Terrace
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Royal Children's Hospital (Melbourne)
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Children's Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
ZIP/Postal Code
5006
Country
Australia
Facility Name
Universitatsklinik fur Kinder und Jugenheilkunde, Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
LandesKrankenHaus Tulln, Kinderabteilung
City
Tulln
ZIP/Postal Code
A-3430
Country
Austria
Facility Name
Allgemeines KrankenHaus Universitatsklinkiken Wein
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
SMZ-Ost Donauspital Wien
City
Wien
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
Hospital e Maternidade Celso Pierro-Puccamp
City
Campinas
ZIP/Postal Code
13059-900
Country
Brazil
Facility Name
Mernidade Nossa Senhora De Fatima
City
Curitiba
ZIP/Postal Code
80010-100
Country
Brazil
Facility Name
Hospital De Clinicas Da UFPR
City
Curitiba
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina
City
Ribeirao Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Hospital e Maternidade Santa Marina
City
Sao Paulo
ZIP/Postal Code
04378-500
Country
Brazil
Facility Name
Hospital Universitario de Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-900
Country
Brazil
Facility Name
Multifunctional Hospital for Active Treatment "Pleven"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment - Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Regional Hospital of Pulmonary Diseases
City
Rousse
ZIP/Postal Code
7004
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pediatric Diseases
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment "St. Marina"
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Alberta Children's Hospital
City
Calgary
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
Queen Elizabeth Hospital
City
Charlottetown
ZIP/Postal Code
PE C1A 8T5
Country
Canada
Facility Name
University Of Alberta/Stollery Children's Hospital
City
Edmonton
ZIP/Postal Code
AB T6G 2J3
Country
Canada
Facility Name
Dalhousie University IWK Health Centre
City
Halifax
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Mcmaster Children's Hospital
City
Hamilton
ZIP/Postal Code
L8S 4J9
Country
Canada
Facility Name
McGill University Health Centre Monteal Children's Hospital
City
Montreal
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Sainte Justine Hospital
City
Montreal
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Centre Hospitalier de L'Universite Laval
City
Quebec City
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
ZIP/Postal Code
STN 0W8
Country
Canada
Facility Name
Children's And Women's Hospital of BC
City
Vancouver
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Victoria General Hospital
City
Victoria
ZIP/Postal Code
V8Z 6R5
Country
Canada
Facility Name
Windsor Regional Hospital
City
Windsor
ZIP/Postal Code
N8W 1L9
Country
Canada
Facility Name
Manitoba Institute Of Child Health University of Manitoba
City
Winnipeg
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Hospital San Jose
City
Independencia
ZIP/Postal Code
1196
Country
Chile
Facility Name
Hospital Clinico de la Universidad de Chile
City
Independencia
Country
Chile
Facility Name
Hospital Dr. Sotero Del Rio
City
Puente Alto
Country
Chile
Facility Name
Hospital Dr. Feliz Buines Cerda
City
Quinta Normal
Country
Chile
Facility Name
Hospital Clinico San Borja Arriaran
City
Santiago
Country
Chile
Facility Name
Hospital Padre Hurtado
City
Santiago
Country
Chile
Facility Name
Nemocnice CB
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czech Republic
Facility Name
FN Hradec Kralove Detska klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Nemocnice s poliklinikou v Moste
City
Most
ZIP/Postal Code
434 64
Country
Czech Republic
Facility Name
Fakultni nemocnice
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
FNsP Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
FN Plzen
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czech Republic
Facility Name
FN Plzen
City
Plzen-Lochotin
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
Vfn 1.Lf Uk
City
Praha 2
ZIP/Postal Code
128 00
Country
Czech Republic
Facility Name
Fakultni Thomayerova nemocnice S poliklinkou
City
Praha 4
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Ustav pro peci o matku a dite
City
Praha 4
ZIP/Postal Code
143 00
Country
Czech Republic
Facility Name
FN Motol Novorozenecke oddeleni
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Batova krajska nemocnice Zlin
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
Facility Name
Paediatrisk Afdeling Herning Centralsygehus
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Hillerod Sygehus Helsevej 2
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Sygehus Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Service de Medecine Neonatale et de reanimation pediatrique
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CHU de Besancon-Hopital Saint-Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CH Chambery
City
Chambery
ZIP/Postal Code
BP1125
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
CHU Montpellier/Hoptial Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU de Nantes/Hospital Mere-Enfant
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHI Poissy/St Germain en Laye
City
Poissy Cedex
ZIP/Postal Code
78300
Country
France
Facility Name
CHU Rennes/Hopital Sud
City
Rennes Cedex
ZIP/Postal Code
35203
Country
France
Facility Name
CHU Rouen
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
CH Pierre Haute
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU Toulouse-Hopital des Enfants
City
Toulouse Cedex 9
ZIP/Postal Code
BP 3119
Country
France
Facility Name
Centre Pediatrique Gatien de Clocheville
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Ruhr-Uni St. Josef Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinikum Duisburg, Wedau Kliniken
City
Duisburg
ZIP/Postal Code
47055
Country
Germany
Facility Name
Uni-Kinderklinik
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Klinik fur Kinder und Jugendliche
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Zentrum Klinische Studien/Universtatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Universtatsklinikum Gottingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Stiftung Hannoversche
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Im Neuenheimer Feld 153
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik und Poliklinik und Jugendiche der Universitat Leipzig
City
Leipzig
ZIP/Postal Code
04137
Country
Germany
Facility Name
Universitatskinderlinik/Zentrum Fur klinische Studien
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Kinderklinik und Kinderpoliklinik
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Stadtisches Krankenhaus Muchen-Harlaching
City
Munchen
ZIP/Postal Code
81545
Country
Germany
Facility Name
Evangelischisches Krankenhaus
City
Oberhausen
ZIP/Postal Code
46047
Country
Germany
Facility Name
Klinikum Oldenberg
City
Oldenberg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Asklepios Kinderklinik Sankt Augustin GmbH
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Facility Name
"P&A Kyriakou" Children's hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Aghia Sofia Children hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Aristotele University of Thessaloniki, General "AXEPA" Hospital
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Hippokration Hospital, University of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
General hospital "Papageorgiou"
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Semmelweis Univ.
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Schopf-Merei Agost Hospital
City
Budapest
ZIP/Postal Code
1092
Country
Hungary
Facility Name
Semmelweis Univ.
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
DEOEC Neonatology Division
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
DEOEC, Dept. of Pediatry
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Petz Aladar Teaching Hospital
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Josa Andras Hospital
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Univ. of Pecs
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Csolnoky Ferenc Hospital
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Children's hospital, Landspitali University Hospital
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Soroka Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnei Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sapir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Laniado Medical Center
City
Natanya
Country
Israel
Facility Name
Schneider Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sourasky Medical Center (Ichilov)
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Poria Medical Center
City
Tiberia
Country
Israel
Facility Name
Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Ospedale Generale di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Azienda USL di Imola - Ospedale di Imola
City
Imola
ZIP/Postal Code
40026
Country
Italy
Facility Name
Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco"
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
City
Messina
ZIP/Postal Code
98100
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
Country
New Zealand
Facility Name
Klinika Neonatologii AM w Białymstoku
City
Białystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka
City
Bydgoszcz
ZIP/Postal Code
85-667
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy
City
Częstochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Morski im. PCK, Oddział Dziecięcy
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c.
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Katedra i Klinika Neonatologii AM w Poznaniu
City
Poznań
ZIP/Postal Code
60-535
Country
Poland
Facility Name
II Klinika Chorób Dzieci PAM, Samodzielny Publiczny
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Klinika Neonatologii AM w Warszawie
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka
City
Warszawa
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii
City
Łódź
ZIP/Postal Code
91-738
Country
Poland
Facility Name
Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pediatric City Hospital #13
City
Moscow
ZIP/Postal Code
103001
Country
Russian Federation
Facility Name
Morozovsky Pediatric City Hospital
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Smolensk State Medical Academy
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
St. Petersburg City Outpatient Hospital #45
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Saint-Petersburg State Pediatric Medical Academy
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
St. Petersburg State Pediatric Medical Academy
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Pediatric City Hospital #1
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Hospital Clinic y Maternistat - Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Sant Joan de Déu (Barcelona)
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital de Cruces
City
Cruces
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Josep Trueta
City
Gerona
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital de Donostia (San Sebastian)
City
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Materno Infantil deJaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital General de Jerez
City
Jerez
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Materno Infantil de Canarias
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz- Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Materno Infantil/Neumología pediátrica
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Clinico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Maternal Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Hospital Universitario La Fe Maternidad
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Xeral-Cíes
City
Vigo
ZIP/Postal Code
36204
Country
Spain
Facility Name
Mälarsjukhuset
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
The Queen Silvia Children's Hospital
City
Goteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Danderyds Sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Üniversitesi
City
Ankara
Country
Turkey
Facility Name
Ege Üniversitesi Tıp Fakültesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylül Üniversitesi Tıp Fakültesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Dumfries and Galloway Royal Infirmary
City
Dumfries
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Princess Anne Hospital
City
Hants
ZIP/Postal Code
SO16 5YA
Country
United Kingdom
Facility Name
Claredon Wing, Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS2 9NS
Country
United Kingdom
Facility Name
St James' University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Queen's Medical Centre Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Sheffield Children's Hospital
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Royal Hampshire County Hospital
City
Winchester
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20008423
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.
Results Reference
result
Learn more about this trial
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
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