A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease
1 other identifier
interventional
1,236
17 countries
152
Brief Summary
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2005
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
February 14, 2012
CompletedFebruary 16, 2012
February 1, 2012
2.7 years
October 1, 2007
January 11, 2012
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects Reporting Adverse Events Through Study Day 150
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Days 0-150
Number of Subjects Reporting Serious Adverse Events Through Study Day 150
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Days 0-150
Number of Subjects Reporting Laboratory Adverse Events
Days 0-150
Secondary Outcomes (9)
The Number of Subjects Hospitalized for RSV Infection.
Days 0-150
The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.
Days 0-150
Number of Subjects Who Had Anti-motavizumab Antibodies Detected
Days 0-150
Mean Trough Serum Concentration of Motavizumab at Pre-dose 1
Pre-dose 1
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1
30 days post-dose 1
- +4 more secondary outcomes
Study Arms (2)
Motavizumab
EXPERIMENTALMotavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Pailvizumab
ACTIVE COMPARATORPalivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Interventions
15 mg/kg IM administered at monthly intervals
Eligibility Criteria
You may qualify if:
- months of age or younger at randomization (child must have been randomized on or before their 24-month birthday)
- Documented, hemodynamically significant CHD
- Unoperated or partially corrected CHD
- Written informed consent obtained from the patient's parent(s)/legal guardian(s) Note: The following children were not eligible: children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Children with acyanotic cardiac lesions must have pulmonary hypertension \[≥ 40 mmHg measured pressure in the pulmonary artery (PA)\] or the need for daily medication to manage CHD.
You may not qualify if:
- Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated
- Hospitalization, unless discharge was anticipated within 21 days
- Anticipated cardiac surgery within two weeks of randomization
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
- Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
- Acute respiratory illness, or other acute infection or illness Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization
- Chronic seizure or evolving or unstable neurologic disorder
- Known immunodeficiency
- Mother with HIV infection (unless the child had been proven to be not infected)
- Known allergy to Ig products
- Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- Receipt of palivizumab (Synagis®) within 3 months prior to randomization
- Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)
- Current participation in other investigational protocols of drugs or biological agents
- Previous participation in MI-CP124 (Season 1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (152)
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Children's Hospital And Health Center
San Diego, California, 92123, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06520-8064, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nemours Children's Clinic Biomedical Research Department
Orlando, Florida, 32801, United States
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Rochester
Rochester, New York, 14642, United States
Suny At Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Univ. of North Carolina
Chapel Hill, North Carolina, 27599-7220, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Children's Cardiology Associates PLLC
Austin, Texas, 78756, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Universitätsklinik für Kinder- und Jugendheilkunde
Innsbruck, 6020, Austria
Allgemeines Krankenhaus Linz
Linz, 4020, Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Wein, Austria
Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis
Antwerp, 2020, Belgium
UZ Brussel
Brussells, 1090, Belgium
Hôpital Universitaire des Enfants Reine
Brussels, 1020, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
University Multifunctional Hospital for Active Treatment
Pleven, Bulgaria
University Mulitiprofile Hospital for Active Treatment "St.Georgi"
Plovdiv, 4002, Bulgaria
Multifunctional Hospital for Active Treatment - Pleven
Plovdiv, Bulgaria
Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse
Rousse, Bulgaria
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
Sofia, Bulgaria
Specialized Hospital for Active Treatment of Pediatric Diseases
Sofia, Bulgaria
University Multifunctional Hospital for Active Treatment
Stara Zagora, Bulgaria
Multifunctional Hospital for Active Treatment - Pleven
Varna, Bulgaria
Children's and Women's Hospital of BC, Room #1R11
Vancouver, British Columbia, V6H 3V4, Canada
IWK Health Center
Halifax, Nova Scotia, B3K 6R8, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
University of Alberta
Edmonton, Canada
Montreal Children's Hospital
Montreal, Canada
Saint Justine Hospital
Montreal, Canada
Children's Hospital Of Eastern Ontario
Ottawa, K1H 8L1, Canada
Saskatchewan Drug Research Institute
Saskatoon SK, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Nemocnice Most, prispevkova organizace
Most, 434 64, Czechia
Fakultni nemocnice Plzen
Plzen - Lochotin, 304 60, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 51, Czechia
Ustav pro peci o matku a dite
Prague, 147 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Fakultni nemocnice Na Bulovce
Prague, 180 81, Czechia
Skejby Sygehus
Århus N, DK-8200, Denmark
Groupe Hospitalier Pelligrin
Bordeaux, 33076, France
CHRU Dijon-Complex du Bocage
Dijon, 21034, France
Centre chirurgical Marie Lannelongue
Le Plessis-Robinson, 93250, France
Hospital de la Conception
Marseille, 13385, France
Hospital Robert Debre
Paris, 75019, France
American Memorial Hospital
Reims, 51092, France
Hospital de Hautepierre
Strasbourg, 67098, France
Hospitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545, Germany
Friedrich-Alexander-Universiät Erlangen Nürnberg
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover
Hanover, 36023, Germany
Universitätsklinikum Schleswig Holstein
Kiel, 24105, Germany
Johannes Gutenberg-Universität
Mainz, 55105, Germany
LMU Klinikum der Universität
München, 81377, Germany
Klinikum Oldenburg
Oldenburg, 26133, Germany
Universitätsklinik Rostock
Rostock, 18055, Germany
Universitätsklinik Rostock
Rostock, 26133, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Semmelweis Egyetem
Budapest, H-1083, Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont
Budapest, H-1096, Hungary
Debreceni Egyetem OEC
Debrecen, H-4012, Hungary
Petz Aladar Megyei Korhaz
Győr, 9023, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, H-3526, Hungary
Josa Andras Korhaz
Nyíregyháza, H-4400, Hungary
Pecsi Tudomanyegyetem
Pécs, H-7623, Hungary
Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika
Szeged, H-6720, Hungary
Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház
Veszprém, H-8200, Hungary
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Medical Center
Haifa, 31096, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Schneider Children's Medical Center of Israel
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
St George University Hospital
Achrafieh- Beirut, Lebanon
American University of Beirut Medical Center
Beirut, 113-6044, Lebanon
Hotel Dieu De France
Beirut, Lebanon
Samodzielny Publiczny Szpital Akademii Medycznej
Bialystok, 15-276, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Wojewodzki Szpital Dzieciecy W Bydgoszczy
Bydgoszcz, 85-667, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika
Lubin, 20-093, Poland
Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznan, 60-535, Poland
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera
Poznan, 60-572, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie
Szczecin, 71-252, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-736, Poland
Kazan State Medical University
Kazan', Russia
Kuban State Medical Academy
Krasnodar, 350086, Russia
Meshalkin Research Institue of Blood circulation
Novosibirsk, 630055, Russia
City Outpatient Clinic #113
Saint Petersburg, 193312, Russia
Saint Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100, Russia
St. Petersburg City Children's Hospital #1
Saint Petersburg, 198205, Russia
Research Cardiology Institute of Tomsk Scientific Center
Tomsk, 634012, Russia
St. Petersburg Pediatric city hospital
Tyumen, 625000, Russia
Hospital Juan Canalejo
A Coruña, 15006, Spain
Hospital de Cruces
Barakaldo, 48903, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
Hospital Sant Joan de Deu
Esplugas de Llobregat, 08950, Spain
Hospital Josep Trueta
Girona, 17007, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Hospital Materno Infantil de Jaen
Jaén, 23007, Spain
Hospital de Jerez
Jerez de la Frontera, 11407, Spain
Hospital Gregorio Marañon
Madrid, 28009, Spain
Hospital La Paz
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Materno Infantil
Málaga, 29011, Spain
Hospital Infantil Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Xeral de Vigo
Vigo, 36204, Spain
Hospital Universitario Miguel Servet
Zaragoza, 5009, Spain
Jan Sunnegardh's- Private Practice
Gothenburg, SE-41685, Sweden
Universitetssjukhuset i Lund
Lund, Sweden
Karolinska University Hospital
Stockholm, SE-17176, Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, 95 NVB, Sweden
Universitetssjukhuset i Lund
Uppsala, 95 NVB, Sweden
Royal Belfast Hospital for Sick Children
Belfast, BT 12 6BE, United Kingdom
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Medway Maritime Hospital
Gillingham, ME7 5NY, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE3 9QP, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Griffin, Senior Director, Clinical Development
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Pamela Griffin, 301-398-0000
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 3, 2007
Study Start
October 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 16, 2012
Results First Posted
February 14, 2012
Record last verified: 2012-02