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

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00129766
Collaborator
(none)
6,635
Enrollment
344
Locations
2
Arms
17.9
Duration (Months)
19.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: motavizumab (MEDI-524)
  • Biological: palivizumab
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6635 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Nov 1, 2004
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
May 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: palivizumab

15 mg/kg administered intramuscularly for 5 monthly doses

Biological: palivizumab
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Other Names:
  • Synagis

    		•
    Experimental: motavizumab (MEDI-524)

    15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of RSV Hospitalization (Includes Deaths by RSV) [Days 0 - 150]

      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).

    2. Number of Participants Reporting Any Adverse Events (AEs) [Days 0 - 150]

      Number of participants reporting one or more AEs

    3. Number of Participants Reporting Any Related AEs [Days 0 - 150]

      Number of participants reporting one or more AEs considered related to study drug by the investigator

    4. Number of Participants Reporting Any Serious Adverse Events (SAEs) [Days 0 - 150]

      Number of participants reporting one or more SAEs

    5. Number of Participants Reporting Any Related SAEs [Days 0 - 150]

      Number of participants reporting one or more SAEs considered related to study drug by the investigator

    6. Number of Participants Reporting AEs by Highest Severity Grade [Days 0 - 150]

      Adverse events events were graded by severity; Level 1, 2, 3, or 4

    7. Number of Participants Who Discontinued Study Drug Due to AEs [Days 0 - 150]

    8. Number of Participants Who Died [Days 0 - 150]

    9. Number of Participants Reporting Changes in Vital Signs From Baseline [Days 0 - 150]

      Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs

    Secondary Outcome Measures

    1. The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) [Day 0 - 150]

      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.

    2. The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups [Days 0 - 150]

      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.

    3. The Incidence of Medically-attended Otitis Media (OM) Infections [Days 0 - 150]

      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.

    4. The Frequency of Prescribed Antibiotics for Medically-attended LRI [Days 0 - 150]

      The average number of presciptions per event per subject was summarized for each treatment group.

    5. The Frequency of Prescribed Antibiotics for Medically-attended OM Infections [Days 0 - 150]

      The average number of presciptions per event per subject was summarized for each treatment group.

    6. The Number of Participants With Anti-motavizumab Antibodies [Day 0 - 120]

      Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.

    7. The Serum Concentrations of Motavizumab at Day 0 [Day 0]

      Mean serum concentrations of motavizumab at Day 0

    8. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1 [30 days post Dose 1]

      Mean serum concentrations of motavizumab at 30 days post Dose 1

    9. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2 [30 days post Dose 2]

      Mean serum concentrations of motavizumab at 30 days post Dose 2

    10. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3 [30 days post Dose 3]

      Mean serum concentrations of motavizumab at 30 days post Dose 3

    11. The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4 [30 days post Dose 4]

      Mean serum concentrations of motavizumab at 30 days post Dose 4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Alabama At Birmingham Birmingham Alabama United States 35233
    2 Alabama Neonatal Medicine OC Pike Road Alabama United States 35233
    3 Maricopa Medical Center Phoenix Arizona United States 85008
    4 Central Arkansas Pediatric Clinic, PA Benton Arkansas United States 72015
    5 The Children's Clinic Of Jonesboro, P.A. Jonesboro Arkansas United States 72401
    6 Arkansas Children's Hospital Research Institute Little Rock Arkansas United States 72202
    7 Arkansas Pediatric Clinic Little Rock Arkansas United States 72205
    8 Little Rock Children's Clinic, PA Little Rock Arkansas United States 72205
    9 Miller Children's Hospital Long Beach California United States 90806
    10 Kaiser Permanente Los Angeles Los Angeles California United States 90027
    11 Children's Hospital of Oakland Oakland California United States 94609
    12 Kaiser Permanente Health Care Plan Oakland California United States 94611
    13 Children's Hospital of Orange County Orange California United States 92868
    14 University of California San Diego California United States 92103
    15 Children's Hospital San Diego San Diego California United States 92123
    16 California Pacific Medical Center San Francisco California United States 94115
    17 Santa Clara Valley Medical Center San Jose California United States 95728
    18 Children's Hospital Denver Colorado United States 80218
    19 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    20 Pediatric Pulmonology, LLC Stamford Connecticut United States 06920
    21 A. I. Dupont Hospital For Children Wilmington Delaware United States 19803
    22 Georgetown University Medical Center Washington District of Columbia United States 20007
    23 Children's National Medical Center Washington District of Columbia United States 20010
    24 Shands Hospital At The University Of Florida Gainesville Florida United States 32610
    25 The Nemours Children's Clinic Jacksonville Florida United States 32207
    26 University Of Miami Medical Center Miami Florida United States 33136
    27 Nemours Children's Clinic Biomedical Research Orlando Florida United States 32801
    28 Univ. S. Florida Pediatrics Ambulatory Care Center Tampa Florida United States 33606
    29 Emory University School Of Medicine Atlanta Georgia United States 30322
    30 Georgia Pediatric Pulmonology Associates Atlanta Georgia United States 30342
    31 The Medical College Of Georgia Augusta Georgia United States 30912
    32 Kapiolani Medical Center for Woman and Children Honolulu Hawaii United States 96826
    33 University of Illinois at Chicago Chicago Illinois United States 60612
    34 Children's Memorial Hospital Chicago Illinois United States 60614
    35 Advocate Hope Children's Hospital Cook Illinois United States 60453
    36 Lutheran General Children's Hospital Park Ridge Illinois United States 60068
    37 James Whitcomb Riley Hospital for Children Indianapolis Indiana United States 46202
    38 Memorial Hospital of South Bend South Bend Indiana United States 46601
    39 University of Louisville Louisville Kentucky United States 40202
    40 Louisiana State University MidCity Clinic Baton Rouge Louisiana United States 70806
    41 Tulane Hospital for Children New Orleans Louisiana United States 70112
    42 University Of Maryland School of Medicine Baltimore Maryland United States 21201
    43 Tufts-New England Medical Center Boston Massachusetts United States 02111
    44 Boston Medical Center Boston Massachusetts United States 02118
    45 Baystate Medical Center Springfield Massachusetts United States 01199
    46 University of Michigan Mott Children's Hospital Ann Arbor Michigan United States 48109
    47 Children's Hospital Of Michigan Detroit Michigan United States 48201
    48 St. John Hospital & Medical Center Detroit Michigan United States 48236
    49 DeVos Children's Hospital Grand Rapids Michigan United States 49503
    50 St. Mary's Duluth Clinic Duluth Minnesota United States 55805
    51 Children's Healthcare D.B.A. Hospitals & Clinics St. Paul Minnesota United States 55102
    52 Children's Mercy Hospital Kansas City Missouri United States 64108
    53 Research Medical Center Kansas City Missouri United States 64132
    54 University of Nebraska Medical Center Pediatric Omaha Nebraska United States 68198
    55 Children's Lung Specialist, Ltd Las Vegas Nevada United States 89107
    56 Dartmouth Medical School Lebanon New Hampshire United States 03756
    57 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    58 New Jersey Medical School Newark New Jersey United States 07103
    59 Albany Medical Center Albany New York United States 12208
    60 Bronx-Lebanon Hospital Center Bronx New York United States 10457
    61 Jacobi Medical Center Bronx New York United States 10461
    62 Montefiore Medical Center Bronx New York United States 10467
    63 The Brooklyn Hospital Center Brooklyn New York United States 11201
    64 Women & Children's Hospital Buffalo New York United States 14222
    65 Winthrop University Hospital Mineola New York United States 11501
    66 Schneider Children's Hospital New Hyde Park New York United States 11040
    67 The Children's Medical Group Poughkeepsie New York United States 12603
    68 University Of Rochester Medical Center Rochester New York United States 14642
    69 University Hospital State University of New York at Stony Brook Department of Pediatrics Stony Brook New York United States 11794
    70 Crouse Hospital NICU Syracuse New York United States 13210
    71 SUNY Upstate Medical University Syracuse New York United States 13210
    72 University of North Carolina-School of Medicine Chapel Hill North Carolina United States 27516
    73 Carolinas Medical Center Charlotte North Carolina United States 28203
    74 Duke University Medical Center Durham North Carolina United States 27710
    75 East Carolina University School of Medicine Greenville North Carolina United States 27858
    76 Raleigh Pediatric Associates Raleigh North Carolina United States 27615
    77 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
    78 Children's Hospital Medical Center Of Akron Akron Ohio United States 44308
    79 Beehly Medical Park Women's and Children's Pav. Boardman Ohio United States 44512
    80 University of Cincinnati Col. of Med. Cincinnati Ohio United States 45267
    81 Metro Health Medical Center Cleveland Ohio United States 44109
    82 Pediatric Clinical Trials International, Inc. Columbus Ohio United States 43205
    83 Children's Medical Center Dayton Ohio United States 45404
    84 Tod Children's Hospital Mahaning Ohio United States 44501
    85 Toledo Children's Hospital Toledo Ohio United States 43606
    86 St. Vincent Medical Center Toledo Ohio United States 43608
    87 Children's Hospital Of Oklahoma Oklahoma City Oklahoma United States 73104-5066
    88 Saint Francis Hospital EOPC Tulsa Oklahoma United States 74136
    89 Oregon Health Sciences University Portland Oregon United States 97239
    90 Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    91 St. Luke's Hospital Bethlehem Pennsylvania United States 18015
    92 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    93 Geisinger Medical Center- JW Children's Hospital Danville Pennsylvania United States 17822
    94 The Children's Hospital Of Philadelphia Philadelphia Pennsylvania United States 19104
    95 Jefferson-duPont Children's Health Program Philadelphia Pennsylvania United States 19107
    96 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    97 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    98 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    99 Rhode Island Hospital Providence Rhode Island United States 02903
    100 MUSC Charleston South Carolina United States 29425
    101 Sioux Valley Hospital University of South Dakota Medical Center Sioux Falls South Dakota United States 57117
    102 Lebonheur Children's Medical Center Memphis Tennessee United States 38103
    103 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    104 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    105 Baylor University Medical Center Dallas Texas United States 75246
    106 Univ. Of Texas Southwestern Medical Center Dallas Texas United States 75390
    107 Texas Children's Hospital Houston Texas United States 77030
    108 University Of Texas Houston Medical School Houston Texas United States 77030
    109 Texas Tech Health Sciences Center Lubbock Texas United States 79415
    110 University Of Texas Health Science Center San Antonio Texas United States 78229
    111 Scott & White Memorial Hospital Temple Texas United States 76508
    112 Primary Children's Medical Center Salt Lake City Utah United States 85113
    113 University of Virginia Hospital Charlottesville Virginia United States 22908
    114 VCU Medical Center Richmond Virginia United States 23298
    115 University Physicians Huntington West Virginia United States 25701
    116 West Virginia University Morgantown West Virginia United States 26506
    117 Marshfield Clinic Marshfield Wisconsin United States 54449
    118 St. Joseph's Hospital Milwaukee Wisconsin United States 53210
    119 Waukesha Memorial Hospital, Inc Waukesha Wisconsin United States 53188
    120 Children's Corporate Center Wauwatosa Wisconsin United States 53226
    121 Hospital Peiade Interzonal General de Augodos Buenos Aires Argentina B1754FWE
    122 Hospital General De Ninos Pedro De Elizalde Buenos Aires Argentina C1270AAN
    123 Sanatorio Trinidad Capital Federal Argentina C145AIN
    124 Hospital Materno Neonatal Cordoba Argentina C5000BJH
    125 The Canberra Hospital Garran Australian Capital Territory Australia 2605
    126 John Hunter Children's Hospital New Lambton New South Wales Australia 2305
    127 Westmead Hospital Westmead New South Wales Australia 2145
    128 Royal Children's Hospital (Brisbane) Herston Queensland Australia 4029
    129 Peninsula Clinical Research Centre Kippa-Ring Queensland Australia 4021
    130 Mater Mothers Hospital Raymond Terrace South Brisbane Queensland Australia 4101
    131 Royal Hobart Hospital Hobart Tasmania Australia 7000
    132 Royal Children's Hospital (Melbourne) Parkville Victoria Australia 3052
    133 Princess Margaret Children's Hospital Subiaco Western Australia Australia 6008
    134 Women's and Children's Hospital North Adelaide Australia 5006
    135 Universitatsklinik fur Kinder und Jugenheilkunde, Graz Graz Austria A-8036
    136 LandesKrankenHaus Tulln, Kinderabteilung Tulln Austria A-3430
    137 Allgemeines KrankenHaus Universitatsklinkiken Wein Wien Austria A-1090
    138 SMZ-Ost Donauspital Wien Wien Austria A-1220
    139 Hospital e Maternidade Celso Pierro-Puccamp Campinas Brazil 13059-900
    140 Mernidade Nossa Senhora De Fatima Curitiba Brazil 80010-100
    141 Hospital De Clinicas Da UFPR Curitiba Brazil 80060-900
    142 Hospital Sao Lucas da PUC-RS de Riberiao Perto da Universidade de Sao Paulo Porto Alegre Brazil 90610-000
    143 Hospital Das Clinicas Da Faculdade De Medicina Ribeirao Preto Brazil 14048-900
    144 Santa Casa de Misericordia de Sao Paulo Sao Paulo Brazil 01221-020
    145 Hospital e Maternidade Santa Marina Sao Paulo Brazil 04378-500
    146 Hospital Universitario de Universidade de Sao Paulo Sao Paulo Brazil 05508-900
    147 Multifunctional Hospital for Active Treatment "Pleven" Pleven Bulgaria 5800
    148 University Multifunctional Hospital for Active Treatment "St. George" Neonatology Clinic Plovdiv Bulgaria 4000
    149 University Multifunctional Hospital for Active Treatment "St. George" Clinic of Pediatrics Plovdiv Bulgaria 4002
    150 Multifunctional Hospital for Active Treatment - Plovdiv Plovdiv Bulgaria 4003
    151 Regional Hospital of Pulmonary Diseases Rousse Bulgaria 7004
    152 Specialized Hospital for Active Treatment of Cardio-vascular Diseases Sofia Bulgaria 1309
    153 Specialized Hospital for Active Treatment of Obstetrics and Gynaecology"-"Maichin Dom" Sofia Bulgaria 1431
    154 Specialized Hospital for Active Treatment of Pediatric Diseases Sofia Bulgaria 1606
    155 Multifunctional Hospital for Active Treatment "St. Marina" Varna Bulgaria 9010
    156 Alberta Children's Hospital Calgary Canada T2T 5C7
    157 Queen Elizabeth Hospital Charlottetown Canada PE C1A 8T5
    158 University Of Alberta/Stollery Children's Hospital Edmonton Canada AB T6G 2J3
    159 Dalhousie University IWK Health Centre Halifax Canada B3K 6R8
    160 Mcmaster Children's Hospital Hamilton Canada L8S 4J9
    161 McGill University Health Centre Monteal Children's Hospital Montreal Canada H3H 1P3
    162 Sainte Justine Hospital Montreal Canada H3T 1C5
    163 Children's Hospital of Eastern Ontario Ottawa Canada K1H 8L1
    164 Centre Hospitalier de L'Universite Laval Quebec City Canada G1V 4G2
    165 Royal University Hospital Saskatoon Canada STN 0W8
    166 Children's And Women's Hospital of BC Vancouver Canada V6H 3V4
    167 Victoria General Hospital Victoria Canada V8Z 6R5
    168 Windsor Regional Hospital Windsor Canada N8W 1L9
    169 Manitoba Institute Of Child Health University of Manitoba Winnipeg Canada R3E 3P4
    170 Hospital San Jose Independencia Chile 1196
    171 Hospital Clinico de la Universidad de Chile Independencia Chile
    172 Hospital Dr. Sotero Del Rio Puente Alto Chile
    173 Hospital Dr. Feliz Buines Cerda Quinta Normal Chile
    174 Hospital Clinico San Borja Arriaran Santiago Chile
    175 Hospital Padre Hurtado Santiago Chile
    176 Nemocnice CB Ceske Budejovice Czech Republic 370 87
    177 FN Hradec Kralove Detska klinika Hradec Kralove Czech Republic 500 05
    178 Nemocnice s poliklinikou v Moste Most Czech Republic 434 64
    179 Fakultni nemocnice Olomouc Czech Republic 775 20
    180 FNsP Ostrava Ostrava Czech Republic 708 52
    181 FN Plzen Plzen-Bory Czech Republic 305 99
    182 FN Plzen Plzen-Lochotin Czech Republic 304 60
    183 Vfn 1.Lf Uk Praha 2 Czech Republic 128 00
    184 Fakultni Thomayerova nemocnice S poliklinkou Praha 4 Czech Republic 140 59
    185 Ustav pro peci o matku a dite Praha 4 Czech Republic 143 00
    186 FN Motol Novorozenecke oddeleni Praha 5 Czech Republic 150 06
    187 Batova krajska nemocnice Zlin Zlin Czech Republic 762 75
    188 Paediatrisk Afdeling Herning Centralsygehus Herning Denmark 7400
    189 Hillerod Sygehus Helsevej 2 Hillerod Denmark 3400
    190 Hvidovre Hospital Hvidovre Denmark 2650
    191 Sygehus Viborg Viborg Denmark 8800
    192 Service de Medecine Neonatale et de reanimation pediatrique Amiens Cedex 1 France 80054
    193 CHU Angers Angers France 49033
    194 CHU de Besancon-Hopital Saint-Jacques Besancon France 25030
    195 CHU Bordeaux/Hopital des enfants/Unite de Neonatologie B Bordeaux France 33076
    196 CH Chambery Chambery France BP1125
    197 CHU Dijon Dijon France 21079
    198 Hopital Jeanne de Flandre Lille France 59037
    199 CHU Nord Marseille France 13915
    200 CHU Montpellier/Hoptial Arnaud de Villeneuve Montpellier France 34000
    201 CHU de Nantes/Hospital Mere-Enfant Nantes France 44093
    202 CHI Poissy/St Germain en Laye Poissy Cedex France 78300
    203 CHU Rennes/Hopital Sud Rennes Cedex France 35203
    204 CHU Rouen Rouen Cedex France 76031
    205 CH Pierre Haute Strasbourg France 67098
    206 CHU Toulouse-Hopital des Enfants Toulouse Cedex 9 France BP 3119
    207 Centre Pediatrique Gatien de Clocheville Tours Cedex France 37044
    208 Ruhr-Uni St. Josef Hospital Bochum Germany 44791
    209 Klinikum Duisburg, Wedau Kliniken Duisburg Germany 47055
    210 Uni-Kinderklinik Dusseldorf Germany 40225
    211 Klinik fur Kinder und Jugendliche Erlangen Germany 91054
    212 Zentrum Klinische Studien/Universtatsklinikum Freiburg Freiburg Germany 79110
    213 Universtatsklinikum Gottingen Gottingen Germany 37075
    214 Wittenberg/Zentrum: fur Kinderheilkunde, Universitatsklinik und Poliklinik fur Kinder and Jugendmedizin Halle Germany 06120
    215 Stiftung Hannoversche Hannover Germany 30173
    216 Im Neuenheimer Feld 153 Heidelberg Germany 69120
    217 Klinik und Poliklinik und Jugendiche der Universitat Leipzig Leipzig Germany 04137
    218 Universitatskinderlinik/Zentrum Fur klinische Studien Mainz Germany 55101
    219 Kinderklinik und Kinderpoliklinik Muenchen Germany 80337
    220 Stadtisches Krankenhaus Muchen-Harlaching Munchen Germany 81545
    221 Evangelischisches Krankenhaus Oberhausen Germany 46047
    222 Klinikum Oldenberg Oldenberg Germany 26133
    223 Klinikum Rosenheim Rosenheim Germany 83022
    224 Asklepios Kinderklinik Sankt Augustin GmbH Sankt Augustin Germany 53757
    225 "P&A Kyriakou" Children's hospital Athens Greece 11527
    226 Aghia Sofia Children hospital Athens Greece 11527
    227 Aristotele University of Thessaloniki, General "AXEPA" Hospital Thessaloniki Greece 54636
    228 Hippokration Hospital, University of Thessaloniki Thessaloniki Greece 54642
    229 General hospital "Papageorgiou" Thessaloniki Greece 56429
    230 Semmelweis Univ. Budapest Hungary 1083
    231 Semmelweis University Budapest Hungary 1088
    232 Schopf-Merei Agost Hospital Budapest Hungary 1092
    233 Semmelweis Univ. Budapest Hungary 1094
    234 DEOEC Neonatology Division Debrecen Hungary 4012
    235 DEOEC, Dept. of Pediatry Debrecen Hungary 4012
    236 Petz Aladar Teaching Hospital Gyor Hungary 9023
    237 Borsod-Abaúj-Zemplén Megyei Önkormányzat Kórháza Miskolc Hungary 3501
    238 Josa Andras Hospital Nyiregyhaza Hungary 4400
    239 University of Pecs Pecs Hungary 7623
    240 Univ. of Pecs Pecs Hungary 7624
    241 Csolnoky Ferenc Hospital Veszprem Hungary 8200
    242 Children's hospital, Landspitali University Hospital Reykjavik Iceland 101
    243 HaEmek Medical Center Afula Israel 18101
    244 Barzilai Medical Center Ashkelon Israel 78306
    245 Soroka Medical Center Beer-Sheva Israel 84101
    246 Bnei Zion Medical Center Haifa Israel 31048
    247 Rambam Medical Center Haifa Israel 31096
    248 Carmel Medical Center Haifa Israel 34362
    249 Wolfson Medical Center Holon Israel 58100
    250 Shaare Zedek Medical Center Jerusalem Israel 91031
    251 Hadassah Ein-Kerem Medical Center Jerusalem Israel 91120
    252 Sapir Medical Center Kfar-Saba Israel 44281
    253 Laniado Medical Center Natanya Israel
    254 Schneider Medical Center Petach Tikva Israel 49100
    255 Kaplan Medical Center Rehovot Israel 76100
    256 Sourasky Medical Center (Ichilov) Tel-Aviv Israel 64239
    257 Chaim Sheba Medical Center Tel-Hashomer Israel 52621
    258 Poria Medical Center Tiberia Israel
    259 Presio Ospedaliero di Alta Specializzazione "G. Salesi" - Azienda Ospedaliera Universitaria - Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi" Ancona Italy 60123
    260 Ospedali Riuniti di Bergamo - Azienda Ospedaliera/Unità Operativa di Patologia Neonatale Bergamo Italy 24128
    261 Azienda Ospedaliera di Bologna - Policlinico S. Orsola - Malpighi Bologna Italy 40139
    262 Ospedale Generale di Bolzano Bolzano Italy 39100
    263 Spedali Civili di Brescia Brescia Italy 25123
    264 Azienda Ospedaliera S. Croce e Carle Cuneo Italy 12100
    265 Azienda Ospedaliera Universitaria Foggia Italy 71100
    266 Azienda USL di Imola - Ospedale di Imola Imola Italy 40026
    267 Ospedale Alessandro Manzoni Lecco - Presidio dell'Azienda Ospedaliera "Ospedale di Lecco" Lecco Italy 23900
    268 Azienda Ospedaliera Universitaria Policlinico Gaetano Martino Messina Italy 98100
    269 Azienda Ospedaliera San Gerardo Monza Italy 20052
    270 Azienda Ospedaliera di Parma Parma Italy 43100
    271 Azienda Ospedaliera Universitaria Pisana - Ospedale S. Chiara Pisa Italy 56100
    272 Azienda Sanitaria Ospedaliera O.I.R.M.-S. Anna Torino Italy 10126
    273 Azienda Ospedaliera S. Maria della Misericordoa Struttura Operativa Complessa di Patologia Neonatale e terapia Intesiva Neonatale Udine Italy 33100
    274 Middlemore Hospital Auckland New Zealand
    275 Dunedin Hospital Dunedin New Zealand
    276 Waikato Hospital Hamilton New Zealand
    277 Palmerston North Hospital Palmerston North New Zealand
    278 Klinika Neonatologii AM w Białymstoku Białystok Poland 15-274
    279 Samodzielny Publiczny Zakład Opieki Zdrowotnej Wojewódzki Szpital im. dr Jana Biziela w Bydgoszczy, Oddział Noworodków, Wcześniaków I Intensywnej Terapii Noworodka Bydgoszcz Poland 85-168
    280 Oddział Pediatrii i Kardiologii z pododdziałem Patologii Noworodka Bydgoszcz Poland 85-667
    281 Wojewódzki Szpital Specjalistyczny, Oddział Dziecięcy Częstochowa Poland 42-200
    282 Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Neonatologii Gdańsk Poland 80-952
    283 Szpital Morski im. PCK, Oddział Dziecięcy Gdynia Poland 81-519
    284 Oddzial Kliniczny Kliniki Neonatologii Szpitala Uniwersyteckiego w Krakowie Krakow Poland 31-501
    285 Niepubliczny Zakład Opieki Zdrowotnej Salmed s.c. Leczna Poland 21-010
    286 Dziecięcy Szpital Kliniczny im. Prof. dr hab. n. med. Antoniego Gębali w Lublinie Lublin Poland 20-093
    287 Katedra i Klinika Neonatologii AM w Poznaniu Poznań Poland 60-535
    288 II Klinika Chorób Dzieci PAM, Samodzielny Publiczny Szczecin Poland 71-252
    289 Klinika Neonatologii AM w Warszawie Warsaw Poland 00-315
    290 Klinika Niemowlęca, Instytut Pomnik - Centrum Zdrowia Dziecka Warszawa Poland 04-736
    291 Szpital Kliniczny nr 4 im.M.Konopnickiej, Oddział Intensywnej Terapii i Anestezjologii Łódź Poland 91-738
    292 Klinika Neonatologii, Instytut Centrum Zdrowia Matki Polki Łódź Poland 93-338
    293 Pediatric City Hospital #13 Moscow Russian Federation 103001
    294 Morozovsky Pediatric City Hospital Moscow Russian Federation 117049
    295 Smolensk State Medical Academy Smolensk Russian Federation 214018
    296 St. Petersburg City Outpatient Hospital #45 St. Petersburg Russian Federation 193312
    297 Saint-Petersburg State Pediatric Medical Academy St. Petersburg Russian Federation 194100
    298 St. Petersburg State Pediatric Medical Academy St. Petersburg Russian Federation 194100
    299 Pediatric City Hospital #1 St. Petersburg Russian Federation 198205
    300 Hospital Clinic y Maternistat - Barcelona Barcelona Spain 08036
    301 Hospital Sant Joan de Déu (Barcelona) Barcelona Spain 08950
    302 Hospital de Cruces Cruces Spain 48903
    303 Hospital Reina Sofia Córdoba Spain 14004
    304 Hospital Josep Trueta Gerona Spain
    305 Hospital Virgen de las Nieves Granada Spain 18014
    306 Hospital de Donostia (San Sebastian) Guipuzcoa Spain 20014
    307 Hospital Materno Infantil deJaén Jaén Spain 23007
    308 Hospital General de Jerez Jerez Spain 11407
    309 Hospital Juan Canalejo La Coruña Spain 15006
    310 Hospital Materno Infantil de Canarias Las Palmas de Gran Canaria Spain
    311 Hospital Clínico San Carlos Madrid Spain 28040
    312 Hospital La Paz- Madrid Madrid Spain 28040
    313 Hospital Severo Ochoa Madrid Spain 28911
    314 Hospital Materno Infantil/Neumología pediátrica Malaga Spain 29011
    315 Hospital Central de Asturias Oviedo Spain 33006
    316 Hospital Clinico de Salamanca Salamanca Spain 37007
    317 Hospital Universitario de Canarias Santa Cruz de Tenerife Spain 38320
    318 Hospital Clinico Universitario de Santiago Santiago de Compostela Spain 15706
    319 Hospital Maternal Virgen del Rocío Sevilla Spain 41013
    320 Hospital Virgen Macarena Sevilla Spain 41071
    321 Hospital Joan XXIII Tarragona Spain 43007
    322 Hospital Universitario La Fe Maternidad Valencia Spain 46009
    323 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    324 Hospital Xeral-Cíes Vigo Spain 36204
    325 Mälarsjukhuset Eskilstuna Sweden 631 88
    326 The Queen Silvia Children's Hospital Goteborg Sweden 41685
    327 Karolinska University Hospital Solna Stockholm Sweden 171 76
    328 Danderyds Sjukhus Stockholm Sweden 182 88
    329 Uppsala University Hospital Uppsala Sweden 751 85
    330 Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi Neonatoloji Ünitesi Ankara Turkey 06100
    331 Ankara Üniversitesi Ankara Turkey
    332 Ege Üniversitesi Tıp Fakültesi Izmir Turkey 35100
    333 Dokuz Eylül Üniversitesi Tıp Fakültesi Izmir Turkey 35340
    334 Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
    335 Dumfries and Galloway Royal Infirmary Dumfries United Kingdom DG1 4AP
    336 Children's Respiratory Medicine Division of Maternal and Child Health Sciences Ninewells Hospital Dundee United Kingdom DD1 9SY
    337 Medway Maritime Hospital Gillingham Kent United Kingdom ME7 5NY
    338 Princess Anne Hospital Hants United Kingdom SO16 5YA
    339 Claredon Wing, Leeds General Infirmary Leeds United Kingdom LS2 9NS
    340 St James' University Hospital Leeds United Kingdom LS9 7TF
    341 James Cook University Hospital Middlesborough United Kingdom TS4 3BW
    342 Queen's Medical Centre Nottingham University Hospital Nottingham United Kingdom NG7 2UH
    343 Sheffield Children's Hospital Sheffield United Kingdom S10 2TH
    344 Royal Hampshire County Hospital Winchester United Kingdom SO22 5DG

    Sponsors and Collaborators

    • MedImmune LLC

    Investigators

    • Study Director: M Pamela Griffin, MD, MedImmune LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MedImmune LLC
    ClinicalTrials.gov Identifier:
    NCT00129766
    Other Study ID Numbers:
    • MI-CP110
    First Posted:
    Aug 12, 2005
    Last Update Posted:
    Aug 28, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by MedImmune LLC
    Respiratory Syncytial Virus (RSV)
    motavizumab
    palivizumab
    Synagis
    Additional relevant MeSH terms:
    Respiratory Syncytial Virus Infections
    Palivizumab

    Study Results

    Participant Flow

    Recruitment Details A total of 6,635 children were randomized in a 1:1 ratio at 347 centers in 24 countries within the Northern and Southern hemispheres between 01/Nov/2004 and 09/Dec/2005; each child participated in the study for a single RSV season.
    Pre-assignment Detail Randomization was blocked by study site and stratified according to presence/absence of CLD of prematurity requiring medical intervention/management.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Period Title: Overall Study
    STARTED 3306 3329
    COMPLETED 3246 3270
    NOT COMPLETED 60 59

    Baseline Characteristics

    Arm/Group Title Palivizumab Motavizumab Total
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Total of all reporting groups
    Overall Participants 3306 3329 6635
    Age (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    3.98
    (3.78)
    3.99
    (3.75)
    3.99
    (3.76)
    Sex: Female, Male (Count of Participants)
    Female
    1495
    45.2%
    1513
    45.4%
    3008
    45.3%
    Male
    1811
    54.8%
    1816
    54.6%
    3627
    54.7%
    Region of Enrollment (participants) [Number]
    United States
    1130
    34.2%
    1167
    35.1%
    2297
    34.6%
    Greece
    32
    1%
    34
    1%
    66
    1%
    Spain
    191
    5.8%
    181
    5.4%
    372
    5.6%
    Turkey
    36
    1.1%
    42
    1.3%
    78
    1.2%
    Austria
    35
    1.1%
    34
    1%
    69
    1%
    Russian Federation
    42
    1.3%
    45
    1.4%
    87
    1.3%
    Israel
    301
    9.1%
    305
    9.2%
    606
    9.1%
    Chile
    93
    2.8%
    87
    2.6%
    180
    2.7%
    United Kingdom
    89
    2.7%
    90
    2.7%
    179
    2.7%
    Italy
    93
    2.8%
    96
    2.9%
    189
    2.8%
    France
    107
    3.2%
    111
    3.3%
    218
    3.3%
    Hungary
    198
    6%
    192
    5.8%
    390
    5.9%
    Czech Republic
    171
    5.2%
    177
    5.3%
    348
    5.2%
    Canada
    134
    4.1%
    132
    4%
    266
    4%
    Argentina
    38
    1.1%
    34
    1%
    72
    1.1%
    Poland
    106
    3.2%
    105
    3.2%
    211
    3.2%
    Brazil
    69
    2.1%
    66
    2%
    135
    2%
    Australia
    85
    2.6%
    81
    2.4%
    166
    2.5%
    Denmark
    30
    0.9%
    27
    0.8%
    57
    0.9%
    Bulgaria
    95
    2.9%
    101
    3%
    196
    3%
    Iceland
    20
    0.6%
    19
    0.6%
    39
    0.6%
    Germany
    131
    4%
    122
    3.7%
    253
    3.8%
    New Zealand
    26
    0.8%
    26
    0.8%
    52
    0.8%
    Sweden
    54
    1.6%
    55
    1.7%
    109
    1.6%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3306 3329
    Number [Participants]
    62
    1.9%
    46
    1.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments ITT population
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.740
    Confidence Interval (2-Sided) 95%
    0.503 to 1.083
    Parameter Dispersion Type:
    Value:
    Estimation Comments Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.
    2. Primary Outcome
    Title Number of Participants Reporting Any Adverse Events (AEs)
    Description Number of participants reporting one or more AEs
    Time Frame Days 0 - 150

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    2837
    85.8%
    2839
    85.3%
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    258
    7.8%
    298
    9%
    4. Primary Outcome
    Title Number of Participants Reporting Any Serious Adverse Events (SAEs)
    Description Number of participants reporting one or more SAEs
    Time Frame Days 0 - 150

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    506
    15.3%
    485
    14.6%
    5. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    8
    0.2%
    9
    0.3%
    6. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Level 1
    1478
    44.7%
    1538
    46.2%
    Level 2
    1006
    30.4%
    976
    29.3%
    Level 3
    292
    8.8%
    271
    8.1%
    Level 4
    61
    1.8%
    54
    1.6%
    7. Primary Outcome
    Title Number of Participants Who Discontinued Study Drug Due to AEs
    Description
    Time Frame Days 0 - 150

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    10
    0.3%
    13
    0.4%
    8. Primary Outcome
    Title Number of Participants Who Died
    Description
    Time Frame Days 0 - 150

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Number [participants]
    4
    0.1%
    8
    0.2%
    9. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Safety Population included all patients who received any study drug and had any safety follow-up.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3298 3315
    Fever neonatal
    0
    0%
    2
    0.1%
    Hyperpyrexia
    0
    0%
    1
    0%
    Hyperthermia
    3
    0.1%
    3
    0.1%
    Hypothermia
    2
    0.1%
    2
    0.1%
    Pyrexia
    559
    16.9%
    544
    16.3%
    Hypertension
    4
    0.1%
    4
    0.1%
    Hypotension
    2
    0.1%
    2
    0.1%
    Arrhythmia
    1
    0%
    0
    0%
    Bradycardia
    10
    0.3%
    4
    0.1%
    Tachycardia
    4
    0.1%
    6
    0.2%
    10. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3306 3329
    Number [Participant]
    696
    648
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.
    Statistical Test of Hypothesis p-Value 0.110
    Comments Test stratified by presence or absence of CLD of prematurity specified on the CRF
    Method Cochran-Mantel-Haenszel
    Comments
    11. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 1183 1227
    Number [Participants]
    46
    1.4%
    24
    0.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.
    Statistical Test of Hypothesis p-Value 0.005
    Comments No adjustment for multiple comparisons.
    Method Cochran-Mantel-Haenszel
    Comments The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF
    12. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3306 3329
    Overall incidence
    461
    13.9%
    484
    14.5%
    0 infections
    2845
    86.1%
    2845
    85.5%
    1 infection
    329
    10%
    360
    10.8%
    2 infections
    100
    3%
    91
    2.7%
    3 or more infections
    32
    1%
    33
    1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments P-value is for overall incidence
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.
    Statistical Test of Hypothesis p-Value 0.476
    Comments
    Method Van Eleteren test
    Comments Test stratified by presence or absence of CLD of prematurity specified on the CRF
    13. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3306 3329
    Mean (Standard Deviation) [Number of prescriptions]
    0.32
    (0.02)
    0.30
    (0.02)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.
    Statistical Test of Hypothesis p-Value 0.493
    Comments Test stratified by presence or absence of CLD of prematurity specified on the CRF
    Method Van Eleteren test
    Comments
    14. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Intent-to-Treat (ITT) Population included all patients randomized into the study.
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3306 3329
    Mean (Standard Deviation) [number of prescriptions]
    1.08
    (0.003)
    1.10
    (0.003)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Palivizumab, Motavizumab
    Comments
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.
    Statistical Test of Hypothesis p-Value 0.652
    Comments Test stratified by presence or absence of CLD of prematurity specified on the CRF
    Method Van Eleteren test
    Comments
    15. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3217
    Pre-dose 1
    7
    0.2%
    30 Days Post-Dose 1
    1
    0%
    30 Days Post-Dose 2
    1
    0%
    30 Days Post-Dose 3
    7
    0.2%
    30 Days Post-Dose 4
    18
    0.5%
    At any time post baseline
    22
    0.7%
    16. Secondary Outcome
    Title The Serum Concentrations of Motavizumab at Day 0
    Description Mean serum concentrations of motavizumab at Day 0
    Time Frame Day 0

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 3147
    Mean (Standard Deviation) [ug/mL]
    0.01193
    (0.2072)
    17. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 974
    Mean (Standard Deviation) [ug/mL]
    45.95
    (15.17)
    18. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 915
    Mean (Standard Deviation) [ug/mL]
    64.59
    (25.60)
    19. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 918
    Mean (Standard Deviation) [ug/mL]
    80.24
    (31.22)
    20. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements
    Arm/Group Title Motavizumab
    Arm/Group Description Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    Measure Participants 2669
    Mean (Standard Deviation) [ug/mL]
    88.52
    (35.43)

    Adverse Events

    Time Frame Day 0 - Day 150
    Adverse Event Reporting Description
    Arm/Group Title Palivizumab Motavizumab
    Arm/Group Description Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
    All Cause Mortality
    Palivizumab Motavizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Palivizumab Motavizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 506/3298 (15.3%) 485/3315 (14.6%)
    Blood and lymphatic system disorders
    ANAEMIA 4/3298 (0.1%) 4 5/3315 (0.2%) 5
    ANAEMIA NEONATAL 3/3298 (0.1%) 3 1/3315 (0%) 1
    CYCLIC NEUTROPENIA 0/3298 (0%) 0 1/3315 (0%) 1
    HAEMOLYTIC ANAEMIA 0/3298 (0%) 0 1/3315 (0%) 1
    HAEMOLYTIC URAEMIC SYNDROME 1/3298 (0%) 1 0/3315 (0%) 0
    IRON DEFICIENCY ANAEMIA 1/3298 (0%) 1 0/3315 (0%) 0
    NEUTROPENIA 2/3298 (0.1%) 2 0/3315 (0%) 0
    THROMBOCYTOPENIA 0/3298 (0%) 0 1/3315 (0%) 1
    Cardiac disorders
    ATRIAL THROMBOSIS 0/3298 (0%) 0 1/3315 (0%) 1
    BRADYCARDIA 4/3298 (0.1%) 4 2/3315 (0.1%) 2
    CARDIAC ARREST 1/3298 (0%) 1 0/3315 (0%) 0
    CARDIAC FAILURE HIGH OUTPUT 1/3298 (0%) 1 0/3315 (0%) 0
    CARDIO-RESPIRATORY ARREST 1/3298 (0%) 1 0/3315 (0%) 0
    CARDIOGENIC SHOCK 1/3298 (0%) 1 0/3315 (0%) 0
    CYANOSIS 2/3298 (0.1%) 2 1/3315 (0%) 1
    SUPRAVENTRICULAR TACHYCARDIA 1/3298 (0%) 1 0/3315 (0%) 0
    TACHYCARDIA 0/3298 (0%) 0 1/3315 (0%) 1
    Congenital, familial and genetic disorders
    ACRODERMATITIS ENTEROPATHICA 0/3298 (0%) 0 1/3315 (0%) 1
    ANAL ATRESIA 0/3298 (0%) 0 1/3315 (0%) 1
    ANKYLOGLOSSIA CONGENITAL 1/3298 (0%) 1 0/3315 (0%) 0
    BRANCHIAL CLEFT CYST 0/3298 (0%) 0 1/3315 (0%) 1
    CEREBRAL PALSY 1/3298 (0%) 2 0/3315 (0%) 0
    CLEFT LIP 0/3298 (0%) 0 2/3315 (0.1%) 2
    CLEFT LIP AND PALATE 1/3298 (0%) 1 0/3315 (0%) 0
    CLEFT PALATE 2/3298 (0.1%) 2 0/3315 (0%) 0
    DACRYOSTENOSIS CONGENITAL 1/3298 (0%) 1 0/3315 (0%) 0
    DERMOID CYST 1/3298 (0%) 1 0/3315 (0%) 0
    HAMARTOMA 1/3298 (0%) 1 0/3315 (0%) 0
    HIP DYSPLASIA 1/3298 (0%) 1 0/3315 (0%) 0
    LIMB REDUCTION DEFECT 0/3298 (0%) 0 1/3315 (0%) 1
    PHIMOSIS 1/3298 (0%) 1 1/3315 (0%) 1
    PILONIDAL CYST CONGENITAL 1/3298 (0%) 1 0/3315 (0%) 0
    PYLORIC STENOSIS 1/3298 (0%) 1 1/3315 (0%) 1
    RESPIRATORY TRACT MALFORMATION 0/3298 (0%) 0 1/3315 (0%) 1
    SYNDACTYLY 0/3298 (0%) 0 1/3315 (0%) 1
    TALIPES 2/3298 (0.1%) 2 2/3315 (0.1%) 7
    TRACHEO-OESOPHAGEAL FISTULA 1/3298 (0%) 3 0/3315 (0%) 0
    VENTRICULAR SEPTAL DEFECT 1/3298 (0%) 2 0/3315 (0%) 0
    Ear and labyrinth disorders
    DEAFNESS 0/3298 (0%) 0 1/3315 (0%) 1
    Eye disorders
    PAPILLOEDEMA 0/3298 (0%) 0 1/3315 (0%) 1
    RETINOPATHY OF PREMATURITY 7/3298 (0.2%) 7 5/3315 (0.2%) 5
    RETINOPATHY PROLIFERATIVE 0/3298 (0%) 0 1/3315 (0%) 1
    Gastrointestinal disorders
    ABDOMINAL DISTENSION 1/3298 (0%) 1 0/3315 (0%) 0
    ABDOMINAL PAIN 3/3298 (0.1%) 3 2/3315 (0.1%) 2
    ABDOMINAL STRANGULATED HERNIA 1/3298 (0%) 1 0/3315 (0%) 0
    ANAL FISTULA 1/3298 (0%) 1 0/3315 (0%) 0
    COLONIC STENOSIS 0/3298 (0%) 0 1/3315 (0%) 1
    CONSTIPATION 0/3298 (0%) 0 2/3315 (0.1%) 2
    DIARRHOEA 5/3298 (0.2%) 6 2/3315 (0.1%) 2
    DYSPEPSIA 1/3298 (0%) 1 1/3315 (0%) 1
    DYSPHAGIA 1/3298 (0%) 1 0/3315 (0%) 0
    ENTERITIS 1/3298 (0%) 1 1/3315 (0%) 1
    ENTEROCOLITIS 1/3298 (0%) 1 2/3315 (0.1%) 2
    ENTEROCUTANEOUS FISTULA 1/3298 (0%) 1 0/3315 (0%) 0
    FAECES DISCOLOURED 0/3298 (0%) 0 1/3315 (0%) 1
    FLATULENCE 2/3298 (0.1%) 2 0/3315 (0%) 0
    GASTROINTESTINAL DISORDER 1/3298 (0%) 1 0/3315 (0%) 0
    GASTROINTESTINAL HAEMORRHAGE 0/3298 (0%) 0 1/3315 (0%) 2
    GASTROOESOPHAGEAL REFLUX DISEASE 21/3298 (0.6%) 22 18/3315 (0.5%) 20
    HIATUS HERNIA 1/3298 (0%) 1 0/3315 (0%) 0
    ILEUS 0/3298 (0%) 0 1/3315 (0%) 1
    INGUINAL HERNIA 57/3298 (1.7%) 58 56/3315 (1.7%) 58
    INGUINAL HERNIA, OBSTRUCTIVE 3/3298 (0.1%) 4 1/3315 (0%) 1
    INTUSSUSCEPTION 1/3298 (0%) 1 0/3315 (0%) 0
    NECROTISING COLITIS 1/3298 (0%) 1 2/3315 (0.1%) 2
    OESOPHAGEAL MASS 0/3298 (0%) 0 1/3315 (0%) 1
    PANCREATITIS 1/3298 (0%) 1 0/3315 (0%) 0
    RECTAL HAEMORRHAGE 1/3298 (0%) 1 0/3315 (0%) 0
    REFLUX OESOPHAGITIS 0/3298 (0%) 0 1/3315 (0%) 1
    REGURGITATION 1/3298 (0%) 1 0/3315 (0%) 0
    UMBILICAL HERNIA 1/3298 (0%) 1 1/3315 (0%) 1
    VOMITING 3/3298 (0.1%) 3 5/3315 (0.2%) 5
    General disorders
    FEVER NEONATAL 0/3298 (0%) 0 2/3315 (0.1%) 2
    HERNIA 1/3298 (0%) 1 0/3315 (0%) 0
    HERNIA OBSTRUCTIVE 0/3298 (0%) 0 1/3315 (0%) 1
    HYPOTHERMIA 1/3298 (0%) 1 1/3315 (0%) 1
    MALAISE 0/3298 (0%) 0 1/3315 (0%) 1
    OEDEMA PERIPHERAL 1/3298 (0%) 1 0/3315 (0%) 0
    PYREXIA 9/3298 (0.3%) 9 10/3315 (0.3%) 11
    SUDDEN DEATH 0/3298 (0%) 0 1/3315 (0%) 1
    SUDDEN INFANT DEATH SYNDROME 2/3298 (0.1%) 2 3/3315 (0.1%) 3
    Hepatobiliary disorders
    CHOLELITHIASIS 1/3298 (0%) 1 0/3315 (0%) 0
    CHOLESTASIS 0/3298 (0%) 0 1/3315 (0%) 1
    HEPATIC CYST 1/3298 (0%) 1 0/3315 (0%) 0
    HYPERBILIRUBINAEMIA 1/3298 (0%) 1 1/3315 (0%) 1
    Immune system disorders
    DRUG HYPERSENSITIVITY 0/3298 (0%) 0 1/3315 (0%) 1
    HYPERSENSITIVITY 0/3298 (0%) 0 1/3315 (0%) 1
    IMMUNISATION REACTION 1/3298 (0%) 1 0/3315 (0%) 0
    Infections and infestations
    ABSCESS LIMB 0/3298 (0%) 0 1/3315 (0%) 1
    ABSCESS NECK 1/3298 (0%) 1 0/3315 (0%) 0
    ADENOVIRAL UPPER RESPIRATORY INFECTION 0/3298 (0%) 0 1/3315 (0%) 1
    BACTERAEMIA 0/3298 (0%) 0 1/3315 (0%) 1
    BACTERIAL ABSCESS CENTRAL NERVOUS SYSTEM 0/3298 (0%) 0 1/3315 (0%) 1
    BACTERIAL PYELONEPHRITIS 0/3298 (0%) 0 1/3315 (0%) 1
    BACTERIAL TRACHEITIS 1/3298 (0%) 2 0/3315 (0%) 0
    BRONCHIOLITIS 78/3298 (2.4%) 88 71/3315 (2.1%) 87
    BRONCHITIS 36/3298 (1.1%) 46 35/3315 (1.1%) 39
    BRONCHITIS VIRAL 3/3298 (0.1%) 3 0/3315 (0%) 0
    BRONCHOPNEUMONIA 8/3298 (0.2%) 8 12/3315 (0.4%) 13
    CATHETER SEPSIS 1/3298 (0%) 1 0/3315 (0%) 0
    CELLULITIS 3/3298 (0.1%) 3 1/3315 (0%) 1
    CENTRAL LINE INFECTION 0/3298 (0%) 0 1/3315 (0%) 1
    CLOSTRIDIAL INFECTION 1/3298 (0%) 1 0/3315 (0%) 0
    CROUP INFECTIOUS 7/3298 (0.2%) 8 6/3315 (0.2%) 6
    CYTOMEGALOVIRUS INFECTION 0/3298 (0%) 0 1/3315 (0%) 1
    DACRYOCYSTITIS 1/3298 (0%) 1 1/3315 (0%) 1
    DYSENTERY 1/3298 (0%) 1 0/3315 (0%) 0
    ENTEROBACTER BACTERAEMIA 0/3298 (0%) 0 1/3315 (0%) 1
    ENTEROCOLITIS VIRAL 0/3298 (0%) 0 1/3315 (0%) 1
    ESCHERICHIA SEPSIS 0/3298 (0%) 0 1/3315 (0%) 1
    ESCHERICHIA URINARY TRACT INFECTION 2/3298 (0.1%) 2 0/3315 (0%) 0
    EXANTHEMA SUBITUM 1/3298 (0%) 1 0/3315 (0%) 0
    EXTERNAL EAR CELLULITIS 0/3298 (0%) 0 1/3315 (0%) 1
    GASTROENTERITIS 31/3298 (0.9%) 31 27/3315 (0.8%) 28
    GASTROENTERITIS ADENOVIRUS 1/3298 (0%) 1 0/3315 (0%) 0
    GASTROENTERITIS ESCHERICHIA COLI 1/3298 (0%) 1 0/3315 (0%) 0
    GASTROENTERITIS ROTAVIRUS 21/3298 (0.6%) 21 13/3315 (0.4%) 15
    GASTROENTERITIS SALMONELLA 0/3298 (0%) 0 1/3315 (0%) 1
    GASTROENTERITIS VIRAL 6/3298 (0.2%) 6 2/3315 (0.1%) 2
    HERPES ZOSTER 1/3298 (0%) 1 0/3315 (0%) 0
    IMPETIGO 1/3298 (0%) 1 0/3315 (0%) 0
    INFECTION 1/3298 (0%) 1 0/3315 (0%) 0
    INFLUENZA 3/3298 (0.1%) 3 4/3315 (0.1%) 4
    LARYNGITIS 5/3298 (0.2%) 7 5/3315 (0.2%) 5
    LOBAR PNEUMONIA 3/3298 (0.1%) 3 2/3315 (0.1%) 2
    LOWER RESPIRATORY TRACT INFECTION 8/3298 (0.2%) 8 6/3315 (0.2%) 6
    LOWER RESPIRATORY TRACT INFECTION VIRAL 1/3298 (0%) 1 0/3315 (0%) 0
    LUNG ABSCESS 1/3298 (0%) 1 0/3315 (0%) 0
    LYMPHADENITIS BACTERIAL 1/3298 (0%) 1 1/3315 (0%) 1
    MENINGITIS VIRAL 0/3298 (0%) 0 1/3315 (0%) 1
    NASOPHARYNGITIS 3/3298 (0.1%) 3 2/3315 (0.1%) 2
    ORAL CANDIDIASIS 0/3298 (0%) 0 1/3315 (0%) 1
    OSTEOMYELITIS 1/3298 (0%) 1 1/3315 (0%) 1
    OTITIS MEDIA 4/3298 (0.1%) 4 3/3315 (0.1%) 3
    OTITIS MEDIA BACTERIAL 0/3298 (0%) 0 1/3315 (0%) 1
    PARAINFLUENZAE VIRUS INFECTION 2/3298 (0.1%) 2 0/3315 (0%) 0
    PERTUSSIS 2/3298 (0.1%) 2 0/3315 (0%) 0
    PHARYNGITIS 1/3298 (0%) 1 0/3315 (0%) 0
    PHARYNGOTONSILLITIS 1/3298 (0%) 1 0/3315 (0%) 0
    PNEUMONIA 31/3298 (0.9%) 31 27/3315 (0.8%) 28
    PNEUMONIA ADENOVIRAL 1/3298 (0%) 1 0/3315 (0%) 0
    PNEUMONIA BACTERIAL 0/3298 (0%) 0 1/3315 (0%) 1
    PNEUMONIA BORDETELLA 0/3298 (0%) 0 1/3315 (0%) 1
    PNEUMONIA INFLUENZAL 3/3298 (0.1%) 4 0/3315 (0%) 0
    PNEUMONIA PARAINFLUENZAE VIRAL 3/3298 (0.1%) 4 1/3315 (0%) 1
    PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL 10/3298 (0.3%) 10 2/3315 (0.1%) 2
    PNEUMONIA VIRAL 1/3298 (0%) 1 3/3315 (0.1%) 3
    POSTOPERATIVE WOUND INFECTION 0/3298 (0%) 0 1/3315 (0%) 1
    PYELONEPHRITIS 1/3298 (0%) 1 2/3315 (0.1%) 2
    PYELONEPHRITIS ACUTE 0/3298 (0%) 0 1/3315 (0%) 1
    RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS 40/3298 (1.2%) 43 25/3315 (0.8%) 25
    RESPIRATORY SYNCYTIAL VIRUS INFECTION 3/3298 (0.1%) 3 3/3315 (0.1%) 3
    RESPIRATORY TRACT INFECTION 2/3298 (0.1%) 2 0/3315 (0%) 0
    RESPIRATORY TRACT INFECTION VIRAL 1/3298 (0%) 1 1/3315 (0%) 1
    RHINITIS 3/3298 (0.1%) 3 1/3315 (0%) 1
    ROTAVIRUS INFECTION 1/3298 (0%) 1 0/3315 (0%) 0
    SEPSIS 2/3298 (0.1%) 2 2/3315 (0.1%) 2
    SINUSITIS 0/3298 (0%) 0 1/3315 (0%) 1
    STAPHYLOCOCCAL INFECTION 0/3298 (0%) 0 1/3315 (0%) 1
    TRACHEITIS 2/3298 (0.1%) 3 0/3315 (0%) 0
    TRACHEOBRONCHITIS 2/3298 (0.1%) 2 0/3315 (0%) 0
    UPPER RESPIRATORY TRACT INFECTION 22/3298 (0.7%) 23 14/3315 (0.4%) 14
    URINARY TRACT INFECTION 7/3298 (0.2%) 7 10/3315 (0.3%) 10
    URINARY TRACT INFECTION BACTERIAL 2/3298 (0.1%) 2 1/3315 (0%) 1
    URINARY TRACT INFECTION ENTEROCOCCAL 1/3298 (0%) 1 1/3315 (0%) 1
    URINARY TRACT INFECTION PSEUDOMONAL 0/3298 (0%) 0 1/3315 (0%) 1
    UROSEPSIS 0/3298 (0%) 0 1/3315 (0%) 1
    VARICELLA 2/3298 (0.1%) 2 0/3315 (0%) 0
    VIRAL INFECTION 7/3298 (0.2%) 7 4/3315 (0.1%) 4
    VIRAL RHINITIS 0/3298 (0%) 0 1/3315 (0%) 1
    VIRAL UPPER RESPIRATORY TRACT INFECTION 2/3298 (0.1%) 2 6/3315 (0.2%) 7
    WOUND INFECTION 0/3298 (0%) 0 1/3315 (0%) 2
    Injury, poisoning and procedural complications
    CHILD MALTREATMENT SYNDROME 0/3298 (0%) 0 1/3315 (0%) 1
    DEVICE MALFUNCTION 0/3298 (0%) 0 1/3315 (0%) 1
    FACE INJURY 0/3298 (0%) 0 1/3315 (0%) 1
    FEEDING TUBE COMPLICATION 0/3298 (0%) 0 1/3315 (0%) 1
    FOREIGN BODY TRAUMA 1/3298 (0%) 1 0/3315 (0%) 0
    HAIR-THREAD TOURNIQUET SYNDROME 0/3298 (0%) 0 1/3315 (0%) 1
    HEAD INJURY 3/3298 (0.1%) 3 1/3315 (0%) 1
    INJURY 1/3298 (0%) 1 0/3315 (0%) 0
    MEDICAL DEVICE COMPLICATION 0/3298 (0%) 0 2/3315 (0.1%) 2
    POST PROCEDURAL DISCHARGE 0/3298 (0%) 0 1/3315 (0%) 1
    SHUNT MALFUNCTION 1/3298 (0%) 1 0/3315 (0%) 0
    SKULL FRACTURE 1/3298 (0%) 1 1/3315 (0%) 1
    SUBDURAL HAEMATOMA 0/3298 (0%) 0 1/3315 (0%) 1
    TRAUMATIC BRAIN INJURY 1/3298 (0%) 1 0/3315 (0%) 0
    VENTRICULOPERITONEAL SHUNT MALFUNCTION 4/3298 (0.1%) 4 2/3315 (0.1%) 3
    VIIITH NERVE INJURY 1/3298 (0%) 1 0/3315 (0%) 0
    Investigations
    BIOPSY RECTUM 0/3298 (0%) 0 1/3315 (0%) 1
    BLOOD BILIRUBIN INCREASED 1/3298 (0%) 1 0/3315 (0%) 0
    CYSTOGRAM 0/3298 (0%) 0 1/3315 (0%) 1
    FALSE POSITIVE LABORATORY RESULT 0/3298 (0%) 0 1/3315 (0%) 1
    HEPATIC ENZYME INCREASED 0/3298 (0%) 0 1/3315 (0%) 1
    INVESTIGATION 1/3298 (0%) 1 0/3315 (0%) 0
    LIVER FUNCTION TEST ABNORMAL 2/3298 (0.1%) 2 0/3315 (0%) 0
    MEDICAL OBSERVATION 1/3298 (0%) 1 2/3315 (0.1%) 2
    NEUROLOGICAL EXAMINATION 2/3298 (0.1%) 2 1/3315 (0%) 1
    OESOPHAGEAL PH 0/3298 (0%) 0 1/3315 (0%) 1
    OXYGEN SATURATION DECREASED 2/3298 (0.1%) 5 0/3315 (0%) 0
    PHYSICAL EXAMINATION 3/3298 (0.1%) 3 3/3315 (0.1%) 3
    WEIGHT DECREASED 2/3298 (0.1%) 2 0/3315 (0%) 0
    Metabolism and nutrition disorders
    ANOREXIA 1/3298 (0%) 1 1/3315 (0%) 1
    COW'S MILK INTOLERANCE 2/3298 (0.1%) 2 0/3315 (0%) 0
    DEHYDRATION 1/3298 (0%) 1 3/3315 (0.1%) 3
    FAILURE TO THRIVE 6/3298 (0.2%) 6 5/3315 (0.2%) 8
    FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD 7/3298 (0.2%) 7 2/3315 (0.1%) 3
    FLUID INTAKE REDUCED 1/3298 (0%) 1 0/3315 (0%) 0
    FLUID OVERLOAD 1/3298 (0%) 1 0/3315 (0%) 0
    HYPERCALCAEMIA 1/3298 (0%) 1 0/3315 (0%) 0
    HYPERNATRAEMIA 0/3298 (0%) 0 1/3315 (0%) 2
    LACTOSE INTOLERANCE 1/3298 (0%) 1 0/3315 (0%) 0
    MALNUTRITION 1/3298 (0%) 1 2/3315 (0.1%) 3
    WEIGHT GAIN POOR 3/3298 (0.1%) 3 2/3315 (0.1%) 2
    ZINC DEFICIENCY 0/3298 (0%) 0 1/3315 (0%) 1
    Musculoskeletal and connective tissue disorders
    CRANIOSYNOSTOSIS 2/3298 (0.1%) 2 2/3315 (0.1%) 2
    MUSCLE CONTRACTURE 0/3298 (0%) 0 1/3315 (0%) 1
    OSTEOPENIA 1/3298 (0%) 1 0/3315 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HAEMANGIOMA 4/3298 (0.1%) 4 4/3315 (0.1%) 7
    Nervous system disorders
    ALTERED STATE OF CONSCIOUSNESS 0/3298 (0%) 0 1/3315 (0%) 1
    CEREBRAL VENTRICLE DILATATION 0/3298 (0%) 0 1/3315 (0%) 1
    CONVULSION 4/3298 (0.1%) 5 3/3315 (0.1%) 5
    CONVULSION NEONATAL 1/3298 (0%) 2 0/3315 (0%) 0
    ENCEPHALITIS 0/3298 (0%) 0 1/3315 (0%) 1
    EPILEPSY 0/3298 (0%) 0 1/3315 (0%) 1
    FEBRILE CONVULSION 0/3298 (0%) 0 1/3315 (0%) 1
    HAEMORRHAGE INTRACRANIAL 0/3298 (0%) 0 1/3315 (0%) 2
    HYDROCEPHALUS 2/3298 (0.1%) 2 5/3315 (0.2%) 5
    HYPERTONIA 0/3298 (0%) 0 1/3315 (0%) 1
    HYPOXIC ENCEPHALOPATHY 3/3298 (0.1%) 4 4/3315 (0.1%) 6
    INTRACRANIAL PRESSURE INCREASED 1/3298 (0%) 1 0/3315 (0%) 0
    LETHARGY 0/3298 (0%) 0 2/3315 (0.1%) 3
    MYOCLONUS 0/3298 (0%) 0 1/3315 (0%) 1
    SOMNOLENCE 1/3298 (0%) 1 0/3315 (0%) 0
    SYNCOPE VASOVAGAL 1/3298 (0%) 1 0/3315 (0%) 0
    VOCAL CORD PARESIS 0/3298 (0%) 0 1/3315 (0%) 1
    Psychiatric disorders
    BREATH HOLDING 2/3298 (0.1%) 2 0/3315 (0%) 0
    RESTLESSNESS 0/3298 (0%) 0 1/3315 (0%) 1
    Renal and urinary disorders
    URETERIC STENOSIS 1/3298 (0%) 1 0/3315 (0%) 0
    Reproductive system and breast disorders
    BALANITIS 1/3298 (0%) 1 0/3315 (0%) 0
    OVARIAN CYST 0/3298 (0%) 0 1/3315 (0%) 1
    SCROTAL OEDEMA 1/3298 (0%) 1 0/3315 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    APNOEA 17/3298 (0.5%) 23 14/3315 (0.4%) 16
    APPARENT LIFE THREATENING EVENT 0/3298 (0%) 0 2/3315 (0.1%) 2
    ASPIRATION 2/3298 (0.1%) 2 2/3315 (0.1%) 2
    ASTHMA 5/3298 (0.2%) 5 7/3315 (0.2%) 7
    ATELECTASIS 0/3298 (0%) 0 2/3315 (0.1%) 3
    BRONCHIAL HYPERREACTIVITY 7/3298 (0.2%) 8 7/3315 (0.2%) 7
    BRONCHOPNEUMOPATHY 1/3298 (0%) 1 0/3315 (0%) 0
    BRONCHOPULMONARY DYSPLASIA 10/3298 (0.3%) 10 9/3315 (0.3%) 11
    BRONCHOSPASM 0/3298 (0%) 0 3/3315 (0.1%) 5
    CHOKING 2/3298 (0.1%) 2 1/3315 (0%) 1
    COUGH 0/3298 (0%) 0 1/3315 (0%) 1
    FOREIGN BODY ASPIRATION 0/3298 (0%) 0 1/3315 (0%) 1
    HYPOVENTILATION 0/3298 (0%) 0 1/3315 (0%) 1
    HYPOXIA 2/3298 (0.1%) 2 1/3315 (0%) 1
    INTERSTITIAL LUNG DISEASE 0/3298 (0%) 0 1/3315 (0%) 1
    LARYNGEAL OEDEMA 1/3298 (0%) 1 0/3315 (0%) 0
    LARYNGEAL STENOSIS 3/3298 (0.1%) 3 1/3315 (0%) 1
    LARYNGOSPASM 1/3298 (0%) 1 0/3315 (0%) 0
    LUNG CONSOLIDATION 0/3298 (0%) 0 1/3315 (0%) 1
    NASAL CONGESTION 1/3298 (0%) 1 0/3315 (0%) 0
    OBSTRUCTIVE AIRWAYS DISORDER 2/3298 (0.1%) 2 0/3315 (0%) 0
    PHARYNGEAL INFLAMMATION 1/3298 (0%) 1 1/3315 (0%) 1
    PNEUMONIA ASPIRATION 2/3298 (0.1%) 2 3/3315 (0.1%) 3
    PNEUMOTHORAX 0/3298 (0%) 0 2/3315 (0.1%) 2
    PULMONARY CONGESTION 1/3298 (0%) 1 0/3315 (0%) 0
    PULMONARY HAEMORRHAGE 0/3298 (0%) 0 1/3315 (0%) 1
    PULMONARY HYPERTENSION 4/3298 (0.1%) 7 2/3315 (0.1%) 2
    PULMONARY HYPERTENSIVE CRISIS 1/3298 (0%) 1 0/3315 (0%) 0
    PULMONARY OEDEMA 1/3298 (0%) 1 1/3315 (0%) 1
    RESPIRATORY DISORDER 1/3298 (0%) 1 2/3315 (0.1%) 4
    RESPIRATORY DISTRESS 1/3298 (0%) 1 2/3315 (0.1%) 2
    RESPIRATORY FAILURE 0/3298 (0%) 0 1/3315 (0%) 1
    SLEEP APNOEA SYNDROME 2/3298 (0.1%) 2 1/3315 (0%) 1
    STATUS ASTHMATICUS 1/3298 (0%) 1 2/3315 (0.1%) 2
    STRIDOR 1/3298 (0%) 1 1/3315 (0%) 2
    TACHYPNOEA 0/3298 (0%) 0 1/3315 (0%) 1
    TONSILLAR HYPERTROPHY 1/3298 (0%) 1 0/3315 (0%) 0
    VOCAL CORD DISORDER 0/3298 (0%) 0 1/3315 (0%) 1
    WHEEZING 3/3298 (0.1%) 3 5/3315 (0.2%) 7
    Skin and subcutaneous tissue disorders
    ANGIOEDEMA 0/3298 (0%) 0 1/3315 (0%) 1
    PETECHIAE 1/3298 (0%) 1 0/3315 (0%) 0
    RASH 0/3298 (0%) 0 1/3315 (0%) 1
    URTICARIA 0/3298 (0%) 0 2/3315 (0.1%) 2
    Social circumstances
    SOCIAL STAY HOSPITALISATION 2/3298 (0.1%) 2 4/3315 (0.1%) 4
    VICTIM OF CHILD ABUSE 0/3298 (0%) 0 1/3315 (0%) 1
    Surgical and medical procedures
    CENTRAL VENOUS CATHETERISATION 0/3298 (0%) 0 1/3315 (0%) 1
    COLOSTOMY CLOSURE 1/3298 (0%) 1 0/3315 (0%) 0
    EAR TUBE INSERTION 1/3298 (0%) 1 0/3315 (0%) 0
    GASTROSTOMY CLOSURE 0/3298 (0%) 0 1/3315 (0%) 1
    GASTROSTOMY TUBE INSERTION 0/3298 (0%) 0 1/3315 (0%) 1
    ILEOSTOMY CLOSURE 3/3298 (0.1%) 3 0/3315 (0%) 0
    NUTRITIONAL SUPPORT 1/3298 (0%) 1 0/3315 (0%) 0
    VENTRICULO-PERITONEAL SHUNT 0/3298 (0%) 0 1/3315 (0%) 1
    Vascular disorders
    HAEMORRHAGE 1/3298 (0%) 1 0/3315 (0%) 0
    HYPERTENSION 2/3298 (0.1%) 4 0/3315 (0%) 0
    Other (Not Including Serious) Adverse Events
    Palivizumab Motavizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2777/3298 (84.2%) 2784/3315 (84%)
    Blood and lymphatic system disorders
    ANAEMIA 73/3298 (2.2%) 75 66/3315 (2%) 67
    Congenital, familial and genetic disorders
    DACRYOSTENOSIS CONGENITAL 33/3298 (1%) 34 35/3315 (1.1%) 37
    Eye disorders
    CONJUNCTIVITIS 251/3298 (7.6%) 285 246/3315 (7.4%) 271
    Gastrointestinal disorders
    ABDOMINAL PAIN 70/3298 (2.1%) 73 54/3315 (1.6%) 55
    CONSTIPATION 227/3298 (6.9%) 262 234/3315 (7.1%) 265
    DIARRHOEA 274/3298 (8.3%) 306 254/3315 (7.7%) 295
    FLATULENCE 119/3298 (3.6%) 135 126/3315 (3.8%) 170
    GASTROOESOPHAGEAL REFLUX DISEASE 190/3298 (5.8%) 198 190/3315 (5.7%) 197
    TEETHING 282/3298 (8.6%) 408 299/3315 (9%) 417
    UMBILICAL HERNIA 63/3298 (1.9%) 63 77/3315 (2.3%) 77
    VOMITING 164/3298 (5%) 179 158/3315 (4.8%) 174
    General disorders
    INJECTION SITE ERYTHEMA 28/3298 (0.8%) 38 41/3315 (1.2%) 52
    INJECTION SITE PAIN 49/3298 (1.5%) 94 45/3315 (1.4%) 81
    IRRITABILITY 164/3298 (5%) 243 193/3315 (5.8%) 299
    PYREXIA 556/3298 (16.9%) 729 543/3315 (16.4%) 718
    Immune system disorders
    IMMUNISATION REACTION 97/3298 (2.9%) 122 102/3315 (3.1%) 138
    Infections and infestations
    BRONCHIOLITIS 222/3298 (6.7%) 263 193/3315 (5.8%) 226
    BRONCHITIS 260/3298 (7.9%) 356 230/3315 (6.9%) 328
    CANDIDIASIS 79/3298 (2.4%) 93 58/3315 (1.7%) 65
    GASTROENTERITIS 207/3298 (6.3%) 223 199/3315 (6%) 212
    GASTROENTERITIS VIRAL 32/3298 (1%) 36 40/3315 (1.2%) 40
    LOWER RESPIRATORY TRACT INFECTION 133/3298 (4%) 165 130/3315 (3.9%) 159
    NASOPHARYNGITIS 262/3298 (7.9%) 333 240/3315 (7.2%) 325
    ORAL CANDIDIASIS 107/3298 (3.2%) 120 101/3315 (3%) 113
    OTITIS MEDIA 418/3298 (12.7%) 565 432/3315 (13%) 575
    OTITIS MEDIA ACUTE 54/3298 (1.6%) 79 65/3315 (2%) 83
    PHARYNGITIS 91/3298 (2.8%) 101 70/3315 (2.1%) 81
    PNEUMONIA 35/3298 (1.1%) 39 15/3315 (0.5%) 15
    RHINITIS 444/3298 (13.5%) 593 440/3315 (13.3%) 600
    UPPER RESPIRATORY TRACT INFECTION 981/3298 (29.7%) 1482 956/3315 (28.8%) 1420
    VIRAL INFECTION 98/3298 (3%) 112 86/3315 (2.6%) 103
    VIRAL UPPER RESPIRATORY TRACT INFECTION 60/3298 (1.8%) 64 56/3315 (1.7%) 64
    Investigations
    BLOOD UREA INCREASED 25/3298 (0.8%) 25 35/3315 (1.1%) 35
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HAEMANGIOMA 38/3298 (1.2%) 41 29/3315 (0.9%) 34
    Psychiatric disorders
    AGITATION 47/3298 (1.4%) 61 35/3315 (1.1%) 51
    Respiratory, thoracic and mediastinal disorders
    ASTHMA 37/3298 (1.1%) 45 33/3315 (1%) 37
    BRONCHIAL HYPERREACTIVITY 54/3298 (1.6%) 62 44/3315 (1.3%) 48
    COUGH 216/3298 (6.5%) 262 220/3315 (6.6%) 260
    NASAL CONGESTION 265/3298 (8%) 326 269/3315 (8.1%) 318
    RESPIRATORY DISORDER 275/3298 (8.3%) 374 295/3315 (8.9%) 380
    RHINORRHOEA 92/3298 (2.8%) 112 99/3315 (3%) 124
    WHEEZING 70/3298 (2.1%) 85 51/3315 (1.5%) 61
    Skin and subcutaneous tissue disorders
    DERMATITIS ATOPIC 53/3298 (1.6%) 55 44/3315 (1.3%) 48
    DERMATITIS DIAPER 192/3298 (5.8%) 233 177/3315 (5.3%) 199
    DRY SKIN 25/3298 (0.8%) 26 35/3315 (1.1%) 37
    ECZEMA 95/3298 (2.9%) 100 132/3315 (4%) 140
    RASH 103/3298 (3.1%) 110 130/3315 (3.9%) 147
    SEBORRHOEIC DERMATITIS 52/3298 (1.6%) 53 56/3315 (1.7%) 57

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

    Results Point of Contact

    Name/Title M. Pamela Griffin, Sr. Director, Clinical Development
    Organization MedImmune
    Phone 301-398-0000
    Email clinicaltrialenquiries@medimmune.com
    Responsible Party:
    MedImmune LLC
    ClinicalTrials.gov Identifier:
    NCT00129766
    Other Study ID Numbers:
    • MI-CP110
    First Posted:
    Aug 12, 2005
    Last Update Posted:
    Aug 28, 2013
    Last Verified:
    Jun 1, 2013