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A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00538785
Collaborator
(none)
1,236
Enrollment
153
Locations
2
Arms
32
Duration (Months)
8.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

Condition or Disease Intervention/Treatment Phase
  • Biological: Motavizumab
  • Biological: Palivizumab
 Phase 2

Detailed Description

The primary objective was to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant congenital heart disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
1236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motavizumab

Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Biological: Motavizumab
15 mg/kg IM administered at monthly intervals
Other Names:
  • Medi-524

    		•
    Active Comparator: Pailvizumab

    Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

    Biological: Palivizumab
    15 mg/kg IM administered at monthly intervals
    Other Names:
  • Synagis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects Reporting Adverse Events Through Study Day 150 [Days 0-150]

      Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.

    2. Number of Subjects Reporting Serious Adverse Events Through Study Day 150 [Days 0-150]

      Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.

    3. Number of Subjects Reporting Laboratory Adverse Events [Days 0-150]

    Secondary Outcome Measures

    1. The Number of Subjects Hospitalized for RSV Infection. [Days 0-150]

      An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).

    2. The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only. [Days 0-150]

      An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.

    3. Number of Subjects Who Had Anti-motavizumab Antibodies Detected [Days 0-150]

      ECLA-based method

    4. Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 [Pre-dose 1]

      Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1

    5. Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 [30 days post-dose 1]

      Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1

    6. Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 [30 days post-dose 2]

      Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2

    7. Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 [30 days post-dose 3]

      Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3

    8. Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4 [30 days post-dose 4]

      Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4

    9. Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass [Days 0-150]

      Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.

    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 have been randomized on or before their 24-month birthday)

    • Documented, hemodynamically significant CHD

    • Unoperated or partially corrected CHD

    • Written informed consent obtained from the patient's parent(s)/legal guardian(s) Note: The following children were not eligible: children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Children with acyanotic cardiac lesions must have pulmonary hypertension [≥ 40 mmHg measured pressure in the pulmonary artery (PA)] or the need for daily medication to manage CHD.

    Exclusion Criteria:

    • Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated

    • Hospitalization, unless discharge was anticipated within 21 days

    • Anticipated cardiac surgery within two weeks of randomization

    • Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support

    • Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function

    • Acute respiratory illness, or other acute infection or illness Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization

    • Chronic seizure or evolving or unstable neurologic disorder

    • Known immunodeficiency

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

    • Known allergy to Ig products

    • Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization

    • Receipt of palivizumab (Synagis®) within 3 months prior to randomization

    • Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)

    • Current participation in other investigational protocols of drugs or biological agents

    • Previous participation in MI-CP124 (Season 1)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Pediatric Clinic Little Rock Arkansas United States 72205
    2 Miller Children's Hospital Long Beach California United States 90806
    3 Childrens Hospital Los Angeles Los Angeles California United States 90027
    4 Children's Hospital and Research Center at Oakland Oakland California United States 94609
    5 University of California Davis Medical Center Sacramento California United States 95817
    6 Children's Hospital And Health Center San Diego California United States 92123
    7 Yale New Haven Children's Hospital New Haven Connecticut United States 06520-8064
    8 Children's National Medical Center Washington District of Columbia United States 20010
    9 Nemours Children's Clinic Biomedical Research Department Orlando Florida United States 32801
    10 James Whitcomb Riley Hospital for Children Indianapolis Indiana United States 46202
    11 Memorial Hospital of South Bend South Bend Indiana United States 46601
    12 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    13 University of Maryland Baltimore Maryland United States 21201
    14 Johns Hopkins Hospital Baltimore Maryland United States 21287
    15 Tufts - New England Medical Center Boston Massachusetts United States 02111
    16 Children's Hospital Boston Boston Massachusetts United States 02115
    17 Children's Hospital of Michigan Detroit Michigan United States 48201
    18 Mayo Clinic Rochester Minnesota United States 55905
    19 Children's Mercy Hospital Kansas City Missouri United States 64108
    20 Washington University School of Medicine St. Louis Missouri United States 63110
    21 University of Rochester Rochester New York United States 14642
    22 Suny At Stony Brook University Medical Center Stony Brook New York United States 11794
    23 Univ. of North Carolina Chapel Hill North Carolina United States 27599-7220
    24 Akron Children's Hospital Akron Ohio United States 44308
    25 Children's Hospital of Oklahoma Oklahoma City Oklahoma United States 73104
    26 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    27 Rhode Island Hospital Providence Rhode Island United States 02903
    28 Children's Cardiology Associates PLLC Austin Texas United States 78756
    29 Texas Children's Hospital Houston Texas United States 77030
    30 University of Virginia Charlottesville Virginia United States 22908
    31 Universitätsklinik für Kinder- und Jugendheilkunde Innsbruck Austria 6020
    32 Allgemeines Krankenhaus Linz Linz Austria 4020
    33 Universitätsklinik für Kinder- und Jugendheilkunde Wein Austria
    34 Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis Antwerpen Belgium 2020
    35 UZ Brussel Brussel, Belgium 1090
    36 UZ Brussel Brussells Belgium 1090
    37 Hôpital Universitaire des Enfants Reine Bruxelles Belgium 1020
    38 Cliniques Universitaires Saint-Luc Bruxelles Belgium 1200
    39 UZ Antwerpen Edegem, Belgium 2650
    40 UZ Antwerpen Edegem Belgium 2650
    41 UZ Gent Gent Belgium
    42 UZ Leuven Leuven Belgium 3000
    43 CHR de la Citadelle Liège Belgium 4000
    44 University Multifunctional Hospital for Active Treatment Pleven Bulgaria
    45 University Mulitiprofile Hospital for Active Treatment "St.Georgi" Plovdiv Bulgaria 4002
    46 Multifunctional Hospital for Active Treatment - Pleven Plovdiv Bulgaria
    47 Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse Rousse Bulgaria
    48 Specialized Hospital for Active Treatment of Cardio-vascular Diseases Sofia Bulgaria
    49 Specialized Hospital for Active Treatment of Pediatric Diseases Sofia Bulgaria
    50 University Multifunctional Hospital for Active Treatment Stara Zagora Bulgaria
    51 Multifunctional Hospital for Active Treatment - Pleven Varna Bulgaria
    52 Children's and Women's Hospital of BC, Room #1R11 Vancouver British Columbia Canada V6H 3V4
    53 IWK Health Center Halifax Nova Scotia Canada B3K 6R8
    54 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    55 University of Alberta Edmonton Canada
    56 Montreal Children's Hospital Montreal Canada
    57 Saint Justine Hospital Montreal Canada
    58 Children's Hospital Of Eastern Ontario Ottawa Canada K1H 8L1
    59 Saskatchewan Drug Research Institute Saskatoon SK Canada
    60 Fakultni nemocnice Hradec Kralove Hradec Kralove Czech Republic 500 05
    61 Nemocnice Most, prispevkova organizace Most Czech Republic 434 64
    62 Fakultni nemocnice Plzen Plzen - Lochotin Czech Republic 304 60
    63 Vseobecna fakultni nemocnice v Praze Praha 2 Czech Republic 128 51
    64 Ustav pro peci o matku a dite Praha 4 Czech Republic 147 00
    65 Fakultni nemocnice v Motole Praha 5 Czech Republic 150 06
    66 Fakultni nemocnice Na Bulovce Praha 8 Czech Republic 180 81
    67 Skejby Sygehus Århus N Denmark DK-8200
    68 Groupe Hospitalier Pelligrin Bordeaux France 33076
    69 CHRU Dijon-Complex du Bocage Dijon France 21034
    70 Centre chirurgical Marie Lannelongue Le Plessis Robinson France 93250
    71 Hospital de la Conception Marseille France 13385
    72 Hospital Robert Debre Paris France 75019
    73 American Memorial Hospital Reims France 51092
    74 Hospital de Hautepierre Strasbourg France 67098
    75 Hospitaux de Brabois Vandoeuvre les Nancy France 54511
    76 Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545
    77 Friedrich-Alexander-Universiät Erlangen Nürnberg Freiburg Germany 79106
    78 Medizinische Hochschule Hannover Hanover Germany 36023
    79 Universitätsklinikum Schleswig Holstein Kiel Germany 24105
    80 Johannes Gutenberg-Universität Mainz Germany 55105
    81 LMU Klinikum der Universität München Germany 81377
    82 Klinikum Oldenburg Oldenburg Germany 26133
    83 Universitätsklinik Rostock Rostock Germany 18055
    84 Universitätsklinik Rostock Rostock Germany 26133
    85 Universitätsklinikum Tübingen Tübingen Germany 72076
    86 Semmelweis Egyetem Budapest Hungary H-1083
    87 Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont Budapest Hungary H-1096
    88 Debreceni Egyetem OEC Debrecen Hungary H-4012
    89 Petz Aladar Megyei Korhaz Gyor Hungary 9023
    90 Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Miskolc Hungary H-3526
    91 Josa Andras Korhaz Nyiregyhaza Hungary H-4400
    92 Pecsi Tudomanyegyetem Pecs Hungary H-7623
    93 Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika Szeged Hungary H-6720
    94 Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház Veszprem Hungary H-8200
    95 Soroka University Medical Center Beer Sheva Israel 84101
    96 Rambam Medical Center Haifa Israel 31096
    97 Edith Wolfson Medical Center Holon Israel 58100
    98 Shaare Zedek Medical Center Jerusalem Israel 91031
    99 Hadassah University Hospital Ein Kerem Jerusalem Israel 91120
    100 Schneider Children's Medical Center of Israel Petach Tikva Israel 49100
    101 The Chaim Sheba Medical Center Ramat-Gan Israel 52621
    102 Tel-Aviv Sourasky Medical Center Tel Aviv Israel 64239
    103 The Chaim Sheba Medical Center Tel Hashomer Israel 52621
    104 St George University Hospital Achrafieh- Beirut Lebanon
    105 American University of Beirut Medical Center Beirut Lebanon 113-6044
    106 Hotel Dieu De France Beirut Lebanon
    107 Samodzielny Publiczny Szpital Akademii Medycznej Bialystok Poland 15-276
    108 Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy Bydgoszcz Poland 85-168
    109 Wojewodzki Szpital Dzieciecy W Bydgoszczy Bydgoszcz Poland 85-667
    110 Instytut Centrum Zdrowia Matki Polki Lodz Poland 93-338
    111 Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika Lubin Poland 20-093
    112 Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu Poznan Poland 60-535
    113 Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera Poznan Poland 60-572
    114 Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie Szczecin Poland 71-252
    115 Instytut "Pomnik - Centrum Zdrowia Dziecka" Warszawa Poland 04-736
    116 Kazan State Medical University Kazan Russian Federation
    117 Kuban State Medical Academy Krasnodar Russian Federation 350086
    118 Meshalkin Research Institue of Blood circulation Novosibirsk Russian Federation 630055
    119 City Outpatient Clinic #113 St. Petersburg Russian Federation 193312
    120 Saint Petersburg State Pediatric Medical Academy St. Petersburg Russian Federation 194100
    121 St. Petersburg City Children's Hospital #1 St. Petersburg Russian Federation 198205
    122 Research Cardiology Institute of Tomsk Scientific Center Tomsk Russian Federation 634012
    123 St. Petersburg Pediatric city hospital Tyumen Russian Federation 625000
    124 Hospital de Cruces Barakaldo Spain 48903
    125 Hospital Vall d'Hebron Barcelona Spain 08035
    126 Hospital Reina Sofia Córdoba Spain 14004
    127 Hospital Universitario Virgen de la Arrixaca El Palmar Spain 30120
    128 Hospital Sant Joan de Deu Esplugas de Llobregat Spain 08950
    129 Hospital Josep Trueta Girona Spain 17007
    130 Hospital Universitario Virgen de Las Nieves Granada Spain 18014
    131 Hospital Materno Infantil de Jaen Jaen Spain 23007
    132 Hospital de Jerez Jerez de la Frontera Spain 11407
    133 Hospital Juan Canalejo La Coruña Spain 15006
    134 Hospital Gregorio Marañon Madrid Spain 28009
    135 Hospital La Paz Madrid Spain 28040
    136 Hospital 12 de Octubre Madrid Spain 28041
    137 Hospital Materno Infantil Málaga Spain 29011
    138 Hospital Donostia San Sebastian Spain 20014
    139 Hospital Infantil Universitario Virgen del Rocío Sevilla Spain 41013
    140 Hospital Xeral de Vigo Vigo Spain 36204
    141 Hospital Universitario Miguel Servet Zaragoza Spain 5009
    142 Jan Sunnegardh's- Private Practice Göteborg Sweden SE-41685
    143 Universitetssjukhuset i Lund Lund Sweden
    144 Karolinska University Hospital Stockholm Sweden SE-17176
    145 Akademiska Sjukhuset i Uppsala Uppsala Sweden 95 NVB
    146 Universitetssjukhuset i Lund Uppsala Sweden 95 NVB
    147 Royal Belfast Hospital for Sick Children Belfast United Kingdom BT 12 6BE
    148 Bristol Royal Hospital for Children Bristol United Kingdom BS2 8BJ
    149 Medway Maritime Hospital Gillingham United Kingdom ME7 5NY
    150 Leeds General Infirmary Leeds United Kingdom LS1 3EX
    151 University Hospitals of Leicester NHS Trust Leicester United Kingdom LE3 9QP
    152 Royal Brompton Hospital London United Kingdom SW3 6NP
    153 Southampton General Hospital Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • MedImmune LLC

    Investigators

    • Study Director: Pamela Griffin, 301-398-0000, MedImmune LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00538785
    Other Study ID Numbers:
    • MI-CP124-S2
    • NCT00240890
    First Posted:
    Oct 3, 2007
    Last Update Posted:
    Feb 16, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by , ,
    Synagis, motavizumab, palivizumab, children, MEDI-524, RSV, congenital hear disease
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital
    Palivizumab

    Study Results

    Participant Flow

    Recruitment Details A total of 1236 subjects were randomized at 162 sites in 16 countries within the northern hemisphere between 21Oct2005 and 14Dec2005 in Season 1 and 02Oct2007 and 31Dec2007 in Season 2; each subject participated in the study for a single RSV season.
    Pre-assignment Detail Subjects were randomized 1:1 on Study Day 0 to receive either 15 mg/kg motavizumab or 15 mg/kg palivizumab. A permuted-block randomization method was used and a separate randomization schedule was generated for each site and cyanotic CHD strata combination.
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Period Title: Overall Study
    STARTED 623 612
    COMPLETED 604 595
    NOT COMPLETED 19 17

    Baseline Characteristics

    Arm/Group Title Motavizumab (MEDI-524) Palivizumab Total
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Total of all reporting groups
    Overall Participants 623 612 1235
    Age (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    8.47
    (6.40)
    8.18
    (6.51)
    8.33
    (6.45)
    Sex: Female, Male (Count of Participants)
    Female
    282
    45.3%
    298
    48.7%
    580
    47%
    Male
    341
    54.7%
    314
    51.3%
    655
    53%
    Race/Ethnicity, Customized (participants) [Number]
    White/Non-hispanic
    540
    86.7%
    529
    86.4%
    1069
    86.6%
    Black
    23
    3.7%
    20
    3.3%
    43
    3.5%
    Hispanic
    21
    3.4%
    23
    3.8%
    44
    3.6%
    Asian
    10
    1.6%
    8
    1.3%
    18
    1.5%
    Other
    29
    4.7%
    32
    5.2%
    61
    4.9%
    Region of Enrollment (participants) [Number]
    United States
    155
    24.9%
    146
    23.9%
    301
    24.4%
    Spain
    31
    5%
    26
    4.2%
    57
    4.6%
    Lebanon
    62
    10%
    66
    10.8%
    128
    10.4%
    Austria
    7
    1.1%
    7
    1.1%
    14
    1.1%
    Israel
    67
    10.8%
    65
    10.6%
    132
    10.7%
    Russian Federation
    32
    5.1%
    34
    5.6%
    66
    5.3%
    United Kingdom
    26
    4.2%
    31
    5.1%
    57
    4.6%
    France
    13
    2.1%
    15
    2.5%
    28
    2.3%
    Czech Republic
    35
    5.6%
    39
    6.4%
    74
    6%
    Hungary
    27
    4.3%
    26
    4.2%
    53
    4.3%
    Canada
    27
    4.3%
    22
    3.6%
    49
    4%
    Belgium
    28
    4.5%
    26
    4.2%
    54
    4.4%
    Poland
    50
    8%
    49
    8%
    99
    8%
    Bulgaria
    18
    2.9%
    18
    2.9%
    36
    2.9%
    Germany
    35
    5.6%
    31
    5.1%
    66
    5.3%
    Sweden
    10
    1.6%
    11
    1.8%
    21
    1.7%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects Reporting Adverse Events Through Study Day 150
    Description Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    The Safety population included all subjects who received any study drug and had any safety follow-up.
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 618 612
    Number [participants]
    575
    92.3%
    566
    92.5%
    2. Primary Outcome
    Title Number of Subjects Reporting Serious Adverse Events Through Study Day 150
    Description Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    The Safety population included all subjects who received any study drug and had any safety follow-up.
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 618 612
    Number [participants]
    292
    46.9%
    304
    49.7%
    3. Primary Outcome
    Title Number of Subjects Reporting Laboratory Adverse Events
    Description
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    Safety population
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 618 612
    Adrenal insufficiency
    3
    0.5%
    3
    0.5%
    Alanine aminotranferase increased
    13
    2.1%
    26
    4.2%
    Anemia
    17
    2.7%
    14
    2.3%
    Aspartate aminotransferase increased
    3
    0.5%
    9
    1.5%
    Bacteria sputum indentified
    1
    0.2%
    1
    0.2%
    Blood alkaline phosphatase increased
    1
    0.2%
    0
    0%
    Blood calcium decreased
    0
    0%
    1
    0.2%
    Blood calcium increased
    2
    0.3%
    0
    0%
    Blood creatinine increased
    0
    0%
    1
    0.2%
    Blood potassium decreased
    1
    0.2%
    1
    0.2%
    Blood potassium increased
    1
    0.2%
    1
    0.2%
    Blood sodium abnormal
    0
    0%
    1
    0.2%
    Blood sodium decreased
    1
    0.2%
    1
    0.2%
    Blood thyroid stimulating hormone increased
    1
    0.2%
    0
    0%
    Blood urea increased
    39
    6.3%
    34
    5.6%
    Brain natriuretic peptide increased
    1
    0.2%
    0
    0%
    C-reactive protein increased
    0
    0%
    5
    0.8%
    Clostridium difficiline toxin test positive
    1
    0.2%
    0
    0%
    Coagulation test abnormal
    1
    0.2%
    1
    0.2%
    Haematocrit drecreased
    0
    0%
    1
    0.2%
    Haemaglobin decreased
    0
    0%
    1
    0.2%
    Hepatic enzyme increased
    3
    0.5%
    3
    0.5%
    Hyperbilirubinemia
    1
    0.2%
    0
    0%
    Hypertransaminasemia
    0
    0%
    1
    0.2%
    Hypothyroidism
    3
    0.5%
    2
    0.3%
    International normalised ratio decreased
    0
    0%
    1
    0.2%
    International normalised ratio increased
    0
    0%
    2
    0.3%
    Iron deficiency anaemia
    1
    0.2%
    0
    0%
    Liver function test abnormal
    3
    0.5%
    2
    0.3%
    Mean cell volume decreased
    1
    0.2%
    0
    0%
    Neutropenia
    1
    0.2%
    0
    0%
    Occult blood positive
    1
    0.2%
    0
    0%
    Oxygen saturation decreased
    9
    1.4%
    4
    0.7%
    Platelet count decreased
    0
    0%
    1
    0.2%
    Renal function test abnormal
    1
    0.2%
    0
    0%
    Thrombocythemia
    1
    0.2%
    0
    0%
    Thrombocytopenia
    1
    0.2%
    5
    0.8%
    Thyroid function test abnormal
    0
    0%
    1
    0.2%
    Transaminases increased
    0
    0%
    2
    0.3%
    Urine output decreased
    1
    0.2%
    1
    0.2%
    White blood cell count increased
    1
    0.2%
    0
    0%
    4. Secondary Outcome
    Title The Number of Subjects Hospitalized for RSV Infection.
    Description An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 623 612
    Number [participants]
    12
    1.9%
    16
    2.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Motavizumab (MEDI-524), Palivizumab
    Comments Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.746
    Confidence Interval (2-Sided) 95%
    0.344 to 1.586
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.
    Description An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    All subjects who were randomized in Season 2
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 304 310
    Number [participant]
    3
    6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Motavizumab (MEDI-524)
    Comments Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.495
    Confidence Interval (2-Sided) 95%
    0.101 to 1.989
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Number of Subjects Who Had Anti-motavizumab Antibodies Detected
    Description ECLA-based method
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 605
    Number [participants]
    9
    1.4%
    7. Secondary Outcome
    Title Mean Trough Serum Concentration of Motavizumab at Pre-dose 1
    Description Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
    Time Frame Pre-dose 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 543
    Mean (Standard Deviation) [ug/mL]
    0.0
    (0.0)
    8. Secondary Outcome
    Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1
    Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
    Time Frame 30 days post-dose 1

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 521
    Mean (Standard Deviation) [ug/mL]
    46.90
    (15.20)
    9. Secondary Outcome
    Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2
    Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
    Time Frame 30 days post-dose 2

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 228
    Mean (Standard Deviation) [ug/mL]
    60.94
    (25.41)
    10. Secondary Outcome
    Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3
    Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3
    Time Frame 30 days post-dose 3

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 203
    Mean (Standard Deviation) [ug/mL]
    66.59
    (34.51)
    11. Secondary Outcome
    Title Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4
    Description Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
    Time Frame 30 days post-dose 4

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 203
    Mean (Standard Deviation) [ug/mL]
    77.87
    (32.75)
    12. Secondary Outcome
    Title Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass
    Description Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.
    Time Frame Days 0-150

    Outcome Measure Data

    Analysis Population Description
    Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.
    Arm/Group Title Motavizumab (MEDI-524)
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    Measure Participants 127
    Mean (Standard Deviation) [ug/mL]
    48.51
    (27.30)

    Adverse Events

    Time Frame Day 0 - Day 150
    Adverse Event Reporting Description
    Arm/Group Title Motavizumab (MEDI-524) Palivizumab
    Arm/Group Description Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection. Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
    All Cause Mortality
    Motavizumab (MEDI-524) Palivizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Motavizumab (MEDI-524) Palivizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 292/618 (47.2%) 304/612 (49.7%)
    Blood and lymphatic system disorders
    ANAEMIA 0/618 (0%) 0 1/612 (0.2%) 1
    THROMBOCYTOPENIA 1/618 (0.2%) 1 0/612 (0%) 0
    Cardiac disorders
    AORTIC VALVE STENOSIS 1/618 (0.2%) 1 1/612 (0.2%) 2
    ATRIOVENTRICULAR BLOCK 0/618 (0%) 0 2/612 (0.3%) 2
    ATRIOVENTRICULAR BLOCK COMPLETE 1/618 (0.2%) 1 1/612 (0.2%) 1
    CARDIAC ANEURYSM 0/618 (0%) 0 1/612 (0.2%) 1
    CARDIAC ARREST 0/618 (0%) 0 3/612 (0.5%) 5
    CARDIAC FAILURE 5/618 (0.8%) 7 7/612 (1.1%) 8
    CARDIAC FAILURE ACUTE 1/618 (0.2%) 1 0/612 (0%) 0
    CARDIAC FAILURE CHRONIC 1/618 (0.2%) 2 0/612 (0%) 0
    CARDIAC FAILURE CONGESTIVE 4/618 (0.6%) 4 5/612 (0.8%) 6
    CARDIAC PSEUDOANEURYSM 0/618 (0%) 0 1/612 (0.2%) 1
    CARDIAC TAMPONADE 0/618 (0%) 0 2/612 (0.3%) 2
    CARDIO-RESPIRATORY ARREST 1/618 (0.2%) 1 3/612 (0.5%) 3
    CORONARY ARTERY OCCLUSION 0/618 (0%) 0 1/612 (0.2%) 2
    CYANOSIS 9/618 (1.5%) 9 5/612 (0.8%) 7
    DRESSLER'S SYNDROME 0/618 (0%) 0 1/612 (0.2%) 1
    LEFT VENTRICULAR DYSFUNCTION 1/618 (0.2%) 1 1/612 (0.2%) 1
    MITRAL VALVE STENOSIS 1/618 (0.2%) 3 0/612 (0%) 0
    MYOCARDIAL ISCHAEMIA 1/618 (0.2%) 1 0/612 (0%) 0
    PERICARDIAL EFFUSION 2/618 (0.3%) 2 2/612 (0.3%) 2
    PULMONARY VALVE STENOSIS 0/618 (0%) 0 1/612 (0.2%) 1
    SUPRAVENTRICULAR TACHYCARDIA 2/618 (0.3%) 2 1/612 (0.2%) 1
    TACHYCARDIA 1/618 (0.2%) 1 1/612 (0.2%) 2
    VENTRICULAR DYSFUNCTION 1/618 (0.2%) 1 0/612 (0%) 0
    Congenital, familial and genetic disorders
    ANOMALOUS PULMONARY VENOUS CONNECTION 2/618 (0.3%) 5 2/612 (0.3%) 2
    AORTIC VALVE ATRESIA 1/618 (0.2%) 2 0/612 (0%) 0
    ATRIAL SEPTAL DEFECT 5/618 (0.8%) 5 2/612 (0.3%) 3
    ATRIOVENTRICULAR SEPTAL DEFECT 13/618 (2.1%) 14 22/612 (3.6%) 25
    CHARGE SYNDROME 1/618 (0.2%) 1 0/612 (0%) 0
    CLEFT LIP AND PALATE 0/618 (0%) 0 1/612 (0.2%) 1
    CLEFT PALATE 1/618 (0.2%) 1 0/612 (0%) 0
    COARCTATION OF THE AORTA 3/618 (0.5%) 4 3/612 (0.5%) 3
    CONGENITAL AORTIC DILATATION 1/618 (0.2%) 1 0/612 (0%) 0
    CONGENITAL CORONARY ARTERY MALFORMATION 0/618 (0%) 0 1/612 (0.2%) 1
    CONGENITAL MITRAL VALVE STENOSIS 1/618 (0.2%) 1 0/612 (0%) 0
    CONGENITAL PULMONARY VALVE ATRESIA 8/618 (1.3%) 10 14/612 (2.3%) 17
    CONGENITAL TRICUSPID VALVE ATRESIA 8/618 (1.3%) 11 12/612 (2%) 17
    DEVELOPMENTAL GLAUCOMA 2/618 (0.3%) 2 0/612 (0%) 0
    DOUBLE OUTLET RIGHT VENTRICLE 10/618 (1.6%) 12 7/612 (1.1%) 7
    EBSTEIN'S ANOMALY 0/618 (0%) 0 3/612 (0.5%) 3
    FALLOT'S TETRALOGY 38/618 (6.1%) 45 49/612 (8%) 63
    HEART DISEASE CONGENITAL 4/618 (0.6%) 4 9/612 (1.5%) 10
    HYDROCELE 1/618 (0.2%) 1 0/612 (0%) 0
    HYPOPLASTIC LEFT HEART SYNDROME 16/618 (2.6%) 23 18/612 (2.9%) 22
    HYPOPLASTIC RIGHT HEART SYNDROME 2/618 (0.3%) 3 2/612 (0.3%) 2
    HYPOSPADIAS 0/618 (0%) 0 1/612 (0.2%) 1
    INTERRUPTION OF AORTIC ARCH 1/618 (0.2%) 1 0/612 (0%) 0
    LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION 1/618 (0.2%) 1 0/612 (0%) 0
    MEDIUM-CHAIN ACETYL-COENZYME A DEHYDROGENASE DEFICIENCY 1/618 (0.2%) 1 0/612 (0%) 0
    MITRAL VALVE ATRESIA 0/618 (0%) 0 1/612 (0.2%) 2
    MULTIPLE CARDIAC DEFECTS 0/618 (0%) 0 2/612 (0.3%) 2
    PATENT DUCTUS ARTERIOSUS 4/618 (0.6%) 4 2/612 (0.3%) 2
    PHIMOSIS 0/618 (0%) 0 1/612 (0.2%) 1
    PULMONARY ARTERY ATRESIA 4/618 (0.6%) 4 1/612 (0.2%) 1
    PULMONARY SEQUESTRATION 1/618 (0.2%) 1 0/612 (0%) 0
    PYLORIC STENOSIS 0/618 (0%) 0 1/612 (0.2%) 1
    RIGHT VENTRICLE OUTFLOW TRACT OBSTRUCTION 0/618 (0%) 0 1/612 (0.2%) 1
    SCIMITAR SYNDROME 0/618 (0%) 0 1/612 (0.2%) 2
    SHONE COMPLEX 1/618 (0.2%) 1 0/612 (0%) 0
    TRANSPOSITION OF THE GREAT VESSELS 4/618 (0.6%) 4 6/612 (1%) 6
    TRUNCUS ARTERIOSUS PERSISTENT 1/618 (0.2%) 1 0/612 (0%) 0
    UNIVENTRICULAR HEART 9/618 (1.5%) 10 11/612 (1.8%) 12
    VENTRICULAR SEPTAL DEFECT 29/618 (4.7%) 32 36/612 (5.9%) 38
    DEAFNESS BILATERAL 1/618 (0.2%) 1 0/612 (0%) 0
    Endocrine disorders
    ADRENAL INSUFFICIENCY 1/618 (0.2%) 1 0/612 (0%) 0
    HYPOTHYROIDISM 1/618 (0.2%) 1 0/612 (0%) 0
    Eye disorders
    STRABISMUS 1/618 (0.2%) 1 0/612 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL PAIN 1/618 (0.2%) 1 0/612 (0%) 0
    CONSTIPATION 1/618 (0.2%) 1 0/612 (0%) 0
    DIARRHOEA 2/618 (0.3%) 2 2/612 (0.3%) 2
    ENTERITIS 1/618 (0.2%) 1 3/612 (0.5%) 4
    ENTEROCOLITIS 0/618 (0%) 0 2/612 (0.3%) 2
    ENTEROCUTANEOUS FISTULA 0/618 (0%) 0 1/612 (0.2%) 1
    GASTRITIS 0/618 (0%) 0 2/612 (0.3%) 2
    GASTROINTESTINAL INFLAMMATION 0/618 (0%) 0 1/612 (0.2%) 1
    GASTROOESOPHAGEAL REFLUX DISEASE 4/618 (0.6%) 4 6/612 (1%) 8
    INGUINAL HERNIA 1/618 (0.2%) 1 3/612 (0.5%) 3
    INGUINAL HERNIA, OBSTRUCTIVE 1/618 (0.2%) 1 0/612 (0%) 0
    INTESTINAL ISCHAEMIA 1/618 (0.2%) 1 0/612 (0%) 0
    PERITONEAL HAEMORRHAGE 1/618 (0.2%) 1 0/612 (0%) 0
    RECTAL HAEMORRHAGE 0/618 (0%) 0 1/612 (0.2%) 1
    SPIGELIAN HERNIA 0/618 (0%) 0 1/612 (0.2%) 1
    VOLVULUS 0/618 (0%) 0 1/612 (0.2%) 1
    VOMITING 1/618 (0.2%) 1 4/612 (0.7%) 5
    General disorders
    CATHETER RELATED COMPLICATION 0/618 (0%) 0 1/612 (0.2%) 1
    CYST 1/618 (0.2%) 1 0/612 (0%) 0
    DEATH 0/618 (0%) 0 1/612 (0.2%) 1
    DRUG WITHDRAWAL SYNDROME 0/618 (0%) 0 1/612 (0.2%) 1
    GENERAL PHYSICAL HEALTH DETERIORATION 0/618 (0%) 0 1/612 (0.2%) 1
    IRRITABILITY 0/618 (0%) 0 1/612 (0.2%) 1
    MULTI-ORGAN FAILURE 1/618 (0.2%) 1 0/612 (0%) 0
    PYREXIA 5/618 (0.8%) 6 5/612 (0.8%) 7
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA 0/618 (0%) 0 1/612 (0.2%) 1
    Immune system disorders
    DRUG HYPERSENSITIVITY 1/618 (0.2%) 1 0/612 (0%) 0
    Infections and infestations
    ABDOMINAL SEPSIS 0/618 (0%) 0 1/612 (0.2%) 1
    ADENOVIRAL UPPER RESPIRATORY INFECTION 0/618 (0%) 0 1/612 (0.2%) 1
    ADENOVIRUS INFECTION 1/618 (0.2%) 1 0/612 (0%) 0
    BACTERAEMIA 0/618 (0%) 0 1/612 (0.2%) 1
    BACTERIAL PYELONEPHRITIS 1/618 (0.2%) 1 2/612 (0.3%) 2
    BRONCHIOLITIS 15/618 (2.4%) 27 16/612 (2.6%) 17
    BRONCHITIS 12/618 (1.9%) 16 10/612 (1.6%) 11
    BRONCHITIS VIRAL 0/618 (0%) 0 1/612 (0.2%) 1
    BRONCHOPNEUMONIA 4/618 (0.6%) 4 6/612 (1%) 6
    CELLULITIS 0/618 (0%) 0 2/612 (0.3%) 2
    CLOSTRIDIUM DIFFICILE COLITIS 1/618 (0.2%) 1 1/612 (0.2%) 1
    CROUP INFECTIOUS 2/618 (0.3%) 2 1/612 (0.2%) 1
    EAR INFECTION 2/618 (0.3%) 2 0/612 (0%) 0
    ENDOCARDITIS 2/618 (0.3%) 2 0/612 (0%) 0
    ENDOCARDITIS BACTERIAL 1/618 (0.2%) 1 0/612 (0%) 0
    ENTEROBACTER BACTERAEMIA 1/618 (0.2%) 1 0/612 (0%) 0
    ESCHERICHIA URINARY TRACT INFECTION 1/618 (0.2%) 1 3/612 (0.5%) 3
    GASTROENTERITIS 17/618 (2.8%) 17 18/612 (2.9%) 19
    GASTROENTERITIS NOROVIRUS 0/618 (0%) 0 1/612 (0.2%) 1
    GASTROENTERITIS ROTAVIRUS 7/618 (1.1%) 7 14/612 (2.3%) 14
    GASTROENTERITIS VIRAL 5/618 (0.8%) 5 6/612 (1%) 6
    KLEBSIELLA SEPSIS 1/618 (0.2%) 1 1/612 (0.2%) 1
    LARYNGITIS 1/618 (0.2%) 1 2/612 (0.3%) 2
    LOBAR PNEUMONIA 3/618 (0.5%) 3 1/612 (0.2%) 2
    LOWER RESPIRATORY TRACT INFECTION 4/618 (0.6%) 4 4/612 (0.7%) 4
    LOWER RESPIRATORY TRACT INFECTION VIRAL 0/618 (0%) 0 1/612 (0.2%) 1
    LUNG INFECTION 0/618 (0%) 0 1/612 (0.2%) 1
    LUNG INFECTION PSEUDOMONAL 0/618 (0%) 0 1/612 (0.2%) 1
    LYMPHANGITIS 0/618 (0%) 0 1/612 (0.2%) 1
    MEDIASTINITIS 1/618 (0.2%) 1 2/612 (0.3%) 2
    MENINGITIS MENINGOCOCCAL 1/618 (0.2%) 1 0/612 (0%) 0
    METAPNEUMOVIRUS INFECTION 1/618 (0.2%) 1 0/612 (0%) 0
    NASOPHARYNGITIS 2/618 (0.3%) 3 1/612 (0.2%) 1
    OTITIS MEDIA 5/618 (0.8%) 5 1/612 (0.2%) 1
    OTITIS MEDIA ACUTE 2/618 (0.3%) 2 1/612 (0.2%) 1
    OTITIS MEDIA VIRAL 0/618 (0%) 0 1/612 (0.2%) 1
    PARAINFLUENZAE VIRUS INFECTION 0/618 (0%) 0 3/612 (0.5%) 3
    PHARYNGITIS 2/618 (0.3%) 2 1/612 (0.2%) 1
    PNEUMONIA 20/618 (3.2%) 27 23/612 (3.8%) 24
    PNEUMONIA ADENOVIRAL 0/618 (0%) 0 1/612 (0.2%) 1
    PNEUMONIA INFLUENZAL 0/618 (0%) 0 1/612 (0.2%) 1
    PSEUDOMONAL SEPSIS 1/618 (0.2%) 1 0/612 (0%) 0
    PYELONEPHRITIS 0/618 (0%) 0 1/612 (0.2%) 1
    RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS 6/618 (1%) 6 9/612 (1.5%) 9
    RESPIRATORY SYNCYTIAL VIRUS INFECTION 2/618 (0.3%) 2 4/612 (0.7%) 4
    RESPIRATORY TRACT INFECTION 2/618 (0.3%) 2 4/612 (0.7%) 4
    RESPIRATORY TRACT INFECTION VIRAL 2/618 (0.3%) 2 1/612 (0.2%) 1
    RHINITIS 1/618 (0.2%) 1 0/612 (0%) 0
    ROTAVIRUS INFECTION 1/618 (0.2%) 1 1/612 (0.2%) 1
    SEPSIS 1/618 (0.2%) 1 1/612 (0.2%) 1
    SINUSITIS 1/618 (0.2%) 1 0/612 (0%) 0
    STAPHYLOCOCCAL INFECTION 1/618 (0.2%) 1 0/612 (0%) 0
    STAPHYLOCOCCAL MEDIASTINITIS 1/618 (0.2%) 1 0/612 (0%) 0
    STREPTOCOCCAL BACTERAEMIA 0/618 (0%) 0 1/612 (0.2%) 1
    SUBCUTANEOUS ABSCESS 0/618 (0%) 0 1/612 (0.2%) 1
    TONSILLITIS 1/618 (0.2%) 1 0/612 (0%) 0
    TRACHEITIS 2/618 (0.3%) 2 0/612 (0%) 0
    UPPER RESPIRATORY TRACT INFECTION 11/618 (1.8%) 12 11/612 (1.8%) 12
    URINARY TRACT INFECTION 6/618 (1%) 6 2/612 (0.3%) 2
    URINARY TRACT INFECTION BACTERIAL 1/618 (0.2%) 1 0/612 (0%) 0
    URINARY TRACT INFECTION PSEUDOMONAL 1/618 (0.2%) 1 1/612 (0.2%) 1
    VARICELLA 1/618 (0.2%) 1 0/612 (0%) 0
    VIRAL INFECTION 1/618 (0.2%) 1 1/612 (0.2%) 1
    VIRAL SINUSITIS 1/618 (0.2%) 2 0/612 (0%) 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION 3/618 (0.5%) 3 0/612 (0%) 0
    WOUND INFECTION 1/618 (0.2%) 1 0/612 (0%) 0
    WOUND INFECTION STAPHYLOCOCCAL 0/618 (0%) 0 1/612 (0.2%) 1
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE 0/618 (0%) 0 1/612 (0.2%) 1
    AORTIC INJURY 1/618 (0.2%) 1 0/612 (0%) 0
    CONTUSION 0/618 (0%) 0 1/612 (0.2%) 1
    FEMUR FRACTURE 0/618 (0%) 0 1/612 (0.2%) 1
    HEAD INJURY 0/618 (0%) 0 2/612 (0.3%) 2
    MEDICAL DEVICE COMPLICATION 0/618 (0%) 0 1/612 (0.2%) 2
    MULTIPLE FRACTURES 1/618 (0.2%) 1 0/612 (0%) 0
    POST PROCEDURAL HAEMORRHAGE 2/618 (0.3%) 2 0/612 (0%) 0
    POSTPERICARDIOTOMY SYNDROME 1/618 (0.2%) 1 0/612 (0%) 0
    SEROMA 0/618 (0%) 0 1/612 (0.2%) 1
    SHUNT MALFUNCTION 1/618 (0.2%) 1 0/612 (0%) 0
    SHUNT OCCLUSION 1/618 (0.2%) 1 1/612 (0.2%) 1
    SHUNT STENOSIS 0/618 (0%) 0 1/612 (0.2%) 1
    SUBDURAL HAEMATOMA 1/618 (0.2%) 1 0/612 (0%) 0
    UPPER LIMB FRACTURE 1/618 (0.2%) 1 1/612 (0.2%) 1
    VASCULAR PSEUDOANEURYSM 2/618 (0.3%) 2 0/612 (0%) 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 0/618 (0%) 0 1/612 (0.2%) 1
    C-REACTIVE PROTEIN INCREASED 0/618 (0%) 0 1/612 (0.2%) 1
    CENTRAL VENOUS PRESSURE INCREASED 1/618 (0.2%) 1 0/612 (0%) 0
    COAGULATION TEST ABNORMAL 0/618 (0%) 0 1/612 (0.2%) 1
    HEPATIC ENZYME INCREASED 0/618 (0%) 0 2/612 (0.3%) 2
    LIVER FUNCTION TEST ABNORMAL 0/618 (0%) 0 1/612 (0.2%) 1
    MEDICAL OBSERVATION 2/618 (0.3%) 2 1/612 (0.2%) 2
    SLEEP STUDY 1/618 (0.2%) 1 0/612 (0%) 0
    Metabolism and nutrition disorders
    DEHYDRATION 3/618 (0.5%) 3 1/612 (0.2%) 1
    DIET REFUSAL 0/618 (0%) 0 2/612 (0.3%) 2
    FAILURE TO THRIVE 3/618 (0.5%) 3 5/612 (0.8%) 5
    FEEDING DISORDER 1/618 (0.2%) 1 0/612 (0%) 0
    FEEDING DISORDER OF INFANCY OR EARLY CHILDHOOD 1/618 (0.2%) 1 3/612 (0.5%) 3
    FOOD INTOLERANCE 0/618 (0%) 0 2/612 (0.3%) 2
    HYPOPHAGIA 1/618 (0.2%) 1 2/612 (0.3%) 2
    METABOLIC ACIDOSIS 1/618 (0.2%) 1 0/612 (0%) 0
    WEIGHT GAIN POOR 3/618 (0.5%) 3 2/612 (0.3%) 2
    Musculoskeletal and connective tissue disorders
    SOFT TISSUE NECROSIS 0/618 (0%) 0 1/612 (0.2%) 1
    Nervous system disorders
    ANOXIC ENCEPHALOPATHY 0/618 (0%) 0 1/612 (0.2%) 1
    CEREBRAL INFARCTION 0/618 (0%) 0 1/612 (0.2%) 1
    CEREBROVASCULAR ACCIDENT 1/618 (0.2%) 1 0/612 (0%) 0
    CONVULSION 2/618 (0.3%) 2 1/612 (0.2%) 1
    FEBRILE CONVULSION 1/618 (0.2%) 1 1/612 (0.2%) 1
    MYOCLONUS 0/618 (0%) 0 1/612 (0.2%) 1
    PHRENIC NERVE PARALYSIS 0/618 (0%) 0 1/612 (0.2%) 1
    TONIC CLONIC MOVEMENTS 0/618 (0%) 0 1/612 (0.2%) 1
    Renal and urinary disorders
    NEPHROLITHIASIS 1/618 (0.2%) 1 0/612 (0%) 0
    PYELOCALIECTASIS 0/618 (0%) 0 1/612 (0.2%) 1
    RENAL FAILURE ACUTE 1/618 (0.2%) 1 0/612 (0%) 0
    RENAL TUBULAR NECROSIS 1/618 (0.2%) 1 0/612 (0%) 0
    Reproductive system and breast disorders
    EPIDIDYMITIS 1/618 (0.2%) 1 0/612 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE PULMONARY OEDEMA 0/618 (0%) 0 1/612 (0.2%) 1
    ADENOIDAL HYPERTROPHY 0/618 (0%) 0 1/612 (0.2%) 1
    APNOEA 1/618 (0.2%) 1 3/612 (0.5%) 3
    APNOEIC ATTACK 1/618 (0.2%) 1 0/612 (0%) 0
    ASPIRATION 1/618 (0.2%) 1 2/612 (0.3%) 2
    ATELECTASIS 1/618 (0.2%) 1 2/612 (0.3%) 3
    BRONCHIAL HYPERREACTIVITY 0/618 (0%) 0 1/612 (0.2%) 1
    BRONCHOPULMONARY DYSPLASIA 1/618 (0.2%) 1 0/612 (0%) 0
    BRONCHOSPASM 0/618 (0%) 0 2/612 (0.3%) 2
    CHOKING 1/618 (0.2%) 1 1/612 (0.2%) 1
    CHYLOTHORAX 0/618 (0%) 0 2/612 (0.3%) 2
    COUGH 1/618 (0.2%) 1 0/612 (0%) 0
    DIAPHRAGM MUSCLE WEAKNESS 1/618 (0.2%) 1 0/612 (0%) 0
    DIAPHRAGMATIC HERNIA 1/618 (0.2%) 1 0/612 (0%) 0
    DIAPHRAGMATIC PARALYSIS 1/618 (0.2%) 1 0/612 (0%) 0
    DYSPNOEA 2/618 (0.3%) 2 2/612 (0.3%) 2
    HYPOXIA 1/618 (0.2%) 1 1/612 (0.2%) 1
    LARYNGEAL GRANULOMA 0/618 (0%) 0 1/612 (0.2%) 1
    LUNG CONSOLIDATION 0/618 (0%) 0 1/612 (0.2%) 1
    LUNG INFILTRATION 0/618 (0%) 0 1/612 (0.2%) 1
    PLEURAL EFFUSION 1/618 (0.2%) 1 2/612 (0.3%) 2
    PNEUMONIA ASPIRATION 2/618 (0.3%) 2 3/612 (0.5%) 3
    PNEUMONITIS 1/618 (0.2%) 1 0/612 (0%) 0
    PNEUMOTHORAX 0/618 (0%) 0 1/612 (0.2%) 1
    PULMONARY ARTERY STENOSIS 0/618 (0%) 0 5/612 (0.8%) 6
    PULMONARY CONGESTION 0/618 (0%) 0 1/612 (0.2%) 1
    PULMONARY HYPERTENSION 3/618 (0.5%) 4 2/612 (0.3%) 2
    PULMONARY HYPERTENSIVE CRISIS 1/618 (0.2%) 1 0/612 (0%) 0
    PULMONARY OEDEMA 1/618 (0.2%) 1 1/612 (0.2%) 2
    PULMONARY VEIN OCCLUSION 0/618 (0%) 0 1/612 (0.2%) 1
    PULMONARY VEIN STENOSIS 1/618 (0.2%) 1 0/612 (0%) 0
    RESPIRATORY ARREST 2/618 (0.3%) 2 1/612 (0.2%) 1
    RESPIRATORY DISTRESS 4/618 (0.6%) 4 4/612 (0.7%) 6
    RESPIRATORY FAILURE 2/618 (0.3%) 2 4/612 (0.7%) 5
    STRIDOR 1/618 (0.2%) 1 0/612 (0%) 0
    TACHYPNOEA 0/618 (0%) 0 1/612 (0.2%) 1
    TRACHEOMALACIA 0/618 (0%) 0 2/612 (0.3%) 2
    WHEEZING 0/618 (0%) 0 1/612 (0.2%) 1
    Skin and subcutaneous tissue disorders
    DERMATITIS ALLERGIC 0/618 (0%) 0 1/612 (0.2%) 1
    RASH MACULO-PAPULAR 0/618 (0%) 0 1/612 (0.2%) 1
    URTICARIA 2/618 (0.3%) 2 0/612 (0%) 0
    Social circumstances
    SOCIAL STAY HOSPITALISATION 2/618 (0.3%) 2 0/612 (0%) 0
    Surgical and medical procedures
    IMMUNISATION 1/618 (0.2%) 1 0/612 (0%) 0
    URETHRAL MEATOTOMY 0/618 (0%) 0 1/612 (0.2%) 1
    Vascular disorders
    AORTIC STENOSIS 2/618 (0.3%) 2 0/612 (0%) 0
    ARTERIAL THROMBOSIS LIMB 3/618 (0.5%) 3 1/612 (0.2%) 1
    FEMORAL ARTERY OCCLUSION 1/618 (0.2%) 1 0/612 (0%) 0
    HYPOTENSION 0/618 (0%) 0 1/612 (0.2%) 1
    HYPOVOLAEMIC SHOCK 0/618 (0%) 0 1/612 (0.2%) 1
    THROMBOSIS 1/618 (0.2%) 1 1/612 (0.2%) 1
    VASOSPASM 0/618 (0%) 0 1/612 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    Motavizumab (MEDI-524) Palivizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 553/618 (89.5%) 540/612 (88.2%)
    Blood and lymphatic system disorders
    ANAEMIA 14/618 (2.3%) 15 16/612 (2.6%) 22
    Cardiac disorders
    CARDIAC FAILURE 9/618 (1.5%) 10 10/612 (1.6%) 10
    CYANOSIS 25/618 (4%) 42 25/612 (4.1%) 32
    Eye disorders
    CONJUNCTIVITIS 39/618 (6.3%) 42 27/612 (4.4%) 32
    Gastrointestinal disorders
    CONSTIPATION 44/618 (7.1%) 47 31/612 (5.1%) 35
    DIARRHOEA 69/618 (11.2%) 80 64/612 (10.5%) 70
    FLATULENCE 5/618 (0.8%) 5 6/612 (1%) 7
    ENTERITIS 7/618 (1.1%) 8 4/612 (0.7%) 4
    GASTROOESOPHAGEAL REFLUX DISEASE 19/618 (3.1%) 19 23/612 (3.8%) 23
    TEETHING 44/618 (7.1%) 54 36/612 (5.9%) 56
    VOMITING 59/618 (9.5%) 70 49/612 (8%) 60
    General disorders
    IRRITABILITY 22/618 (3.6%) 33 37/612 (6%) 48
    PYREXIA 180/618 (29.1%) 285 177/612 (28.9%) 286
    Immune system disorders
    IMMUNISATION REACTION 6/618 (1%) 8 8/612 (1.3%) 11
    Infections and infestations
    BRONCHIOLITIS 16/618 (2.6%) 18 10/612 (1.6%) 11
    BRONCHITIS 40/618 (6.5%) 48 41/612 (6.7%) 57
    CANDIDIASIS 6/618 (1%) 6 5/612 (0.8%) 7
    CROUP INFECTIOUS 2/618 (0.3%) 2 9/612 (1.5%) 9
    EAR INFECTION 9/618 (1.5%) 11 7/612 (1.1%) 9
    EXANTHEMA SUBITUM 6/618 (1%) 6 7/612 (1.1%) 7
    GASTROENTERITIS 56/618 (9.1%) 62 48/612 (7.8%) 53
    GASTROENTERITIS VIRAL 9/618 (1.5%) 9 5/612 (0.8%) 5
    INFLUENZA 6/618 (1%) 6 3/612 (0.5%) 3
    LOWER RESPIRATORY TRACT INFECTION 9/618 (1.5%) 12 9/612 (1.5%) 13
    NASOPHARYNGITIS 67/618 (10.8%) 83 57/612 (9.3%) 79
    ORAL CANDIDIASIS 10/618 (1.6%) 10 7/612 (1.1%) 11
    OTITIS MEDIA 73/618 (11.8%) 97 70/612 (11.4%) 95
    OTITIS MEDIA ACUTE 26/618 (4.2%) 30 19/612 (3.1%) 25
    PHARYNGITIS 31/618 (5%) 37 24/612 (3.9%) 28
    PNEUMONIA 11/618 (1.8%) 12 13/612 (2.1%) 14
    RESPIRATORY TRACT INFECTION 11/618 (1.8%) 12 4/612 (0.7%) 5
    RHINITIS 91/618 (14.7%) 115 77/612 (12.6%) 99
    SINUSITIS 10/618 (1.6%) 11 7/612 (1.1%) 8
    TONSILLITIS 18/618 (2.9%) 21 8/612 (1.3%) 8
    UPPER RESPIRATORY TRACT INFECTION 160/618 (25.9%) 235 164/612 (26.8%) 254
    URINARY TRACT INFECTION 12/618 (1.9%) 13 9/612 (1.5%) 9
    VARICELLA 11/618 (1.8%) 11 5/612 (0.8%) 5
    VIRAL INFECTION 38/618 (6.1%) 47 30/612 (4.9%) 33
    VIRAL UPPER RESPIRATORY TRACT INFECTION 12/618 (1.9%) 13 15/612 (2.5%) 16
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 13/618 (2.1%) 13 25/612 (4.1%) 25
    ASPARTATE AMINOTRANSFERASE INCREASED 3/618 (0.5%) 3 9/612 (1.5%) 9
    BLOOD UREA INCREASED 39/618 (6.3%) 39 34/612 (5.6%) 35
    OXYGEN SATURATION DECREASED 9/618 (1.5%) 10 4/612 (0.7%) 5
    WEIGHT DECREASED 7/618 (1.1%) 7 6/612 (1%) 6
    Metabolism and nutrition disorders
    DECREASED APPETITE 4/618 (0.6%) 5 6/612 (1%) 6
    HYPOKALAEMIA 6/618 (1%) 6 5/612 (0.8%) 6
    Psychiatric disorders
    RESTLESSNESS 6/618 (1%) 7 3/612 (0.5%) 3
    Respiratory, thoracic and mediastinal disorders
    ATELECTASIS 3/618 (0.5%) 3 7/612 (1.1%) 7
    COUGH 92/618 (14.9%) 120 71/612 (11.6%) 95
    NASAL CONGESTION 26/618 (4.2%) 31 33/612 (5.4%) 45
    PLEURAL EFFUSION 9/618 (1.5%) 9 6/612 (1%) 7
    PNEUMOTHORAX 2/618 (0.3%) 2 7/612 (1.1%) 7
    RESPIRATORY DISORDER 23/618 (3.7%) 27 28/612 (4.6%) 35
    RHINORRHOEA 49/618 (7.9%) 64 45/612 (7.4%) 70
    WHEEZING 10/618 (1.6%) 10 10/612 (1.6%) 12
    Skin and subcutaneous tissue disorders
    DERMATITIS 7/618 (1.1%) 7 3/612 (0.5%) 3
    DERMATITIS ATOPIC 6/618 (1%) 7 3/612 (0.5%) 3
    DERMATITIS CONTACT 5/618 (0.8%) 5 7/612 (1.1%) 7
    DERMATITIS DIAPER 32/618 (5.2%) 38 31/612 (5.1%) 38
    DRY SKIN 6/618 (1%) 6 2/612 (0.3%) 2
    ECZEMA 11/618 (1.8%) 13 9/612 (1.5%) 9
    RASH 27/618 (4.4%) 27 21/612 (3.4%) 25
    RASH MACULO-PAPULAR 9/618 (1.5%) 10 6/612 (1%) 6

    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 Pamela Griffin, Senior Director, Clinical Development
    Organization MedImmune, LLC
    Phone 301 398 0000
    Email griffinp@medimmune.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00538785
    Other Study ID Numbers:
    • MI-CP124-S2
    • NCT00240890
    First Posted:
    Oct 3, 2007
    Last Update Posted:
    Feb 16, 2012
    Last Verified:
    Feb 1, 2012