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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129766
• Other study ID #: MI-CP110
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2005
• Last updated: June 21, 2013
• Start date: November 2004
• Est. completion date: May 2006

Study information

• Verified date: June 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6635
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization

OR:

• 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

Exclusion Criteria:

• Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)

• Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])

• Life expectancy < 6 months

• Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)

• Known renal impairment

• Known hepatic dysfunction

• Chronic seizure or evolving or unstable neurologic disorder

• Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)

• Known immunodeficiency

• Mother with HIV infection (unless the child has been proven to be not infected)

• Known allergy to Ig products

• Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization

• Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)

• Previous receipt of RSV vaccines

• Participation in other investigational drug product studies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• motavizumab (MEDI-524)
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
• palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Chile,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Iceland,  Israel,  Italy,  New Zealand,  Poland,  Russian Federation,  Spain,  Sweden,  Turkey,  United Kingdom, 

References & Publications (1)

Carbonell-Estrany X, Simões 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of RSV Hospitalization (Includes Deaths by RSV)	RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).	Days 0 - 150	No
Primary	Number of Participants Reporting Any Adverse Events (AEs)	Number of participants reporting one or more AEs	Days 0 - 150	Yes
Primary	Number of Participants Reporting Any Related AEs	Number of participants reporting one or more AEs considered related to study drug by the investigator	Days 0 - 150	Yes
Primary	Number of Participants Reporting Any Serious Adverse Events (SAEs)	Number of participants reporting one or more SAEs	Days 0 - 150	Yes
Primary	Number of Participants Reporting Any Related SAEs	Number of participants reporting one or more SAEs considered related to study drug by the investigator	Days 0 - 150	Yes
Primary	Number of Participants Reporting AEs by Highest Severity Grade	Adverse events events were graded by severity; Level 1, 2, 3, or 4	Days 0 - 150	Yes
Primary	Number of Participants Who Discontinued Study Drug Due to AEs		Days 0 - 150	Yes
Primary	Number of Participants Who Died		Days 0 - 150	Yes
Primary	Number of Participants Reporting Changes in Vital Signs From Baseline	Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs	Days 0 - 150	Yes
Secondary	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.	Day 0 - 150	No
Secondary	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.	Days 0 - 150	No
Secondary	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.	Days 0 - 150	No
Secondary	The Frequency of Prescribed Antibiotics for Medically-attended LRI	The average number of presciptions per event per subject was summarized for each treatment group.	Days 0 - 150	No
Secondary	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.	Days 0 - 150	No
Secondary	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.	Day 0 - 120	No
Secondary	The Serum Concentrations of Motavizumab at Day 0	Mean serum concentrations of motavizumab at Day 0	Day 0	No
Secondary	The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1	Mean serum concentrations of motavizumab at 30 days post Dose 1	30 days post Dose 1	No
Secondary	The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2	Mean serum concentrations of motavizumab at 30 days post Dose 2	30 days post Dose 2	No
Secondary	The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3	Mean serum concentrations of motavizumab at 30 days post Dose 3	30 days post Dose 3	No
Secondary	The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4	Mean serum concentrations of motavizumab at 30 days post Dose 4	30 days post Dose 4	No