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Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01075178
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : February 24, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Severe Respiratory Syncytial Virus Infection
Enrollment 2036
Recruitment Details Infants diagnosed with hemodynamically significant congenital heart disease who were less than 24 months of age when first dosed with palivizumab (CASES) were compared for the occurrence of serious adverse events over an 8-month chart review period with matched infants who did not receive palivizumab during the first 24 months of life (CONTROLS).
Pre-assignment Details  
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
Period Title: Subject Matching
Started 1148 [1] 1421 [1]
Completed 1018 [2] 1018 [2]
Not Completed 130 403
Reason Not Completed
eligible but not matched             130             403
[1]
eligible for matching
[2]
subjects matched
Period Title: Subject Chart Review
Started 1018 [1] 1018 [1]
Completed 1009 [2] 1009 [2]
Not Completed 9 9
Reason Not Completed
died before chart review period             0             2
no data collected due to site closure             3             4
matched partner excluded (reasons above)             6             3
[1]
subjects matched
[2]
subjects in full analysis set
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS) Total
Hide Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab Total of all reporting groups
Overall Number of Baseline Participants 1009 1009 2018
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
<=6 months 651 656 1307
>6 months 358 353 711
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1009 participants 1009 participants 2018 participants
5.4  (4.91) 5.4  (5.05) 5.4  (4.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
Female
437
  43.3%
462
  45.8%
899
  44.5%
Male
572
  56.7%
547
  54.2%
1119
  55.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
France 188 211 399
Slovenia 16 20 36
Spain 284 170 454
Poland 36 242 278
Belgium 77 115 192
Austria 96 53 149
Norway 12 7 19
Germany 97 90 187
United Kingdom 92 59 151
Italy 111 42 153
Cardiac lesion  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
Cyanotic 488 487 975
Acyanotic 521 522 1043
Corrective cardiac surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1009 participants 1009 participants 2018 participants
None 484 485 969
Partially corrected congenital heart disease 525 521 1046
Fully corrected congenital heart disease 0 3 3
1.Primary Outcome
Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death
Hide Description The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event
Time Frame 8-month chart review period in CASES and CONTROLS
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included the full analysis set.
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description:
HSCHD infants, <2 yrs old at first dose of palivizumab
HSCHD infants, <2 yrs old that did not receive palivizumab
Overall Number of Participants Analyzed 1009 1009
Measure Type: Number
Unit of Measure: participants
303 349
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Observed odds ratio
Estimated Value 0.81
Confidence Interval (1-Sided) 95%
0.96
Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
2.Primary Outcome
Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.
Hide Description The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
Time Frame 8-month chart review period in CASES and CONTROLS
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included the full analysis set.
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description:
HSCHD infants, <2 yrs old at first dose of palivizumab
HSCHD infants, <2 yrs old that did not receive palivizumab
Overall Number of Participants Analyzed 1009 1009
Measure Type: Number
Unit of Measure: participants
281 329
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Observed odds ratio
Estimated Value 0.80
Confidence Interval (1-Sided) 95%
0.95
Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
3.Primary Outcome
Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia
Hide Description The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
Time Frame 8-month chart review period in CASES and CONTROLS
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included the full analysis set.
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description:
HSCHD infants, <2 yrs old at first dose of palivizumab
HSCHD infants, <2 yrs old that did not receive palivizumab
Overall Number of Participants Analyzed 1009 1009
Measure Type: Number
Unit of Measure: participants
41 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Observed odds ratio
Estimated Value 1.05
Confidence Interval (1-Sided) 95%
1.64
Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
4.Primary Outcome
Title Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death
Hide Description The number of subjects who died
Time Frame 8-month chart review period in CASES and CONTROLS
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included the full analysis set.
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description:
HSCHD infants, <2 yrs old at first dose of palivizumab
HSCHD infants, <2 yrs old that did not receive palivizumab
Overall Number of Participants Analyzed 1009 1009
Measure Type: Number
Unit of Measure: participants
9 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Palivizumab-treated Subjects (CASES), Non-palivizumab-treated Subjects (CONTROLS)
Comments The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Observed odds ratio
Estimated Value 0.90
Confidence Interval (1-Sided) 95%
2.19
Estimation Comments Result provided for "95% Confidence Interval (1-Sided)" is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS).
Time Frame 8-month chart review period
Adverse Event Reporting Description Only serious adverse events of infection, arrhythmia, and death were collected and assessed as part of the study; other (non-serious) adverse events were not collected or assessed.
 
Arm/Group Title Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Hide Arm/Group Description HSCHD infants, <2 yrs old at first dose of palivizumab HSCHD infants, <2 yrs old that did not receive palivizumab
All-Cause Mortality
Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Affected / at Risk (%) Affected / at Risk (%)
Total   303/1009 (30.03%)   349/1009 (34.59%) 
Cardiac disorders     
Arrhythmia  4/1009 (0.40%)  8/1009 (0.79%) 
Arrhythmia supraventricular  1/1009 (0.10%)  0/1009 (0.00%) 
Atrial fibrillation  0/1009 (0.00%)  1/1009 (0.10%) 
Atrial flutter  1/1009 (0.10%)  0/1009 (0.00%) 
Atrial tachycardia  1/1009 (0.10%)  2/1009 (0.20%) 
Atrioventricular block  4/1009 (0.40%)  3/1009 (0.30%) 
Atrioventricular block complete  1/1009 (0.10%)  4/1009 (0.40%) 
Atrioventricular block second degree  3/1009 (0.30%)  0/1009 (0.00%) 
Bradycardia  2/1009 (0.20%)  5/1009 (0.50%) 
Cardiac arrest  1/1009 (0.10%)  2/1009 (0.20%) 
Cardiac failure  1/1009 (0.10%)  5/1009 (0.50%) 
Extrasystoles  0/1009 (0.00%)  1/1009 (0.10%) 
Myocarditis  0/1009 (0.00%)  1/1009 (0.10%) 
Nodal arrhythmia  6/1009 (0.59%)  7/1009 (0.69%) 
Nodal rhythm  4/1009 (0.40%)  0/1009 (0.00%) 
Pericarditis  1/1009 (0.10%)  1/1009 (0.10%) 
Sinus arrhythmia  1/1009 (0.10%)  0/1009 (0.00%) 
Sinus bradycardia  0/1009 (0.00%)  1/1009 (0.10%) 
Sinus tachycardia  1/1009 (0.10%)  0/1009 (0.00%) 
Supraventricular tachycardia  10/1009 (0.99%)  5/1009 (0.50%) 
Tachycardia  1/1009 (0.10%)  2/1009 (0.20%) 
Ventricular tachycardia  1/1009 (0.10%)  0/1009 (0.00%) 
Cardiogenic shock  1/1009 (0.10%)  0/1009 (0.00%) 
Congestive cardiomyopathy  1/1009 (0.10%)  0/1009 (0.00%) 
Congenital, familial and genetic disorders     
Congenital infection  1/1009 (0.10%)  0/1009 (0.00%) 
Congenital pneumonia  0/1009 (0.00%)  1/1009 (0.10%) 
Heart disease congenital  1/1009 (0.10%)  0/1009 (0.00%) 
Hypoplastic left heart syndrome  1/1009 (0.10%)  0/1009 (0.00%) 
Eye disorders     
Conjunctivitis  0/1009 (0.00%)  1/1009 (0.10%) 
Gastrointestinal disorders     
Diarrhoea  0/1009 (0.00%)  3/1009 (0.30%) 
Dyspepsia  0/1009 (0.00%)  2/1009 (0.20%) 
Enterocolitis  0/1009 (0.00%)  4/1009 (0.40%) 
Gastritis  1/1009 (0.10%)  0/1009 (0.00%) 
Necrotising colitis  0/1009 (0.00%)  1/1009 (0.10%) 
Peritonitis  1/1009 (0.10%)  0/1009 (0.00%) 
Vomiting  0/1009 (0.00%)  1/1009 (0.10%) 
General disorders     
Pyrexia  1/1009 (0.10%)  1/1009 (0.10%) 
Hepatobiliary disorders     
Hepatitis toxic  0/1009 (0.00%)  1/1009 (0.10%) 
Immune system disorders     
Heart transplant rejection  1/1009 (0.10%)  0/1009 (0.00%) 
Infections and infestations     
Acarodermatitis  1/1009 (0.10%)  0/1009 (0.00%) 
Acinetobacter infection  0/1009 (0.00%)  1/1009 (0.10%) 
Adenovirus infection  1/1009 (0.10%)  1/1009 (0.10%) 
Anal abscess  0/1009 (0.00%)  1/1009 (0.10%) 
Bacillus infection  0/1009 (0.00%)  1/1009 (0.10%) 
Bacteraemia  5/1009 (0.50%)  0/1009 (0.00%) 
Bacterial infection  3/1009 (0.30%)  3/1009 (0.30%) 
Bronchiolitis  47/1009 (4.66%)  40/1009 (3.96%) 
Bronchitis  19/1009 (1.88%)  38/1009 (3.77%) 
Bronchitis viral  0/1009 (0.00%)  1/1009 (0.10%) 
Bronchopneumonia  1/1009 (0.10%)  22/1009 (2.18%) 
Candida sepsis  0/1009 (0.00%)  1/1009 (0.10%) 
Candidiasis  0/1009 (0.00%)  1/1009 (0.10%) 
Candiduria  0/1009 (0.00%)  1/1009 (0.10%) 
Catheter sepsis  0/1009 (0.00%)  1/1009 (0.10%) 
Central line infection  2/1009 (0.20%)  1/1009 (0.10%) 
Clostridial infection  0/1009 (0.00%)  1/1009 (0.10%) 
Croup infectious  2/1009 (0.20%)  1/1009 (0.10%) 
Dermatitis infected  0/1009 (0.00%)  1/1009 (0.10%) 
Ear infection  3/1009 (0.30%)  2/1009 (0.20%) 
Endocarditis  1/1009 (0.10%)  0/1009 (0.00%) 
Endicarditis enterococcal  0/1009 (0.00%)  1/1009 (0.10%) 
Enterobacter sepsis  0/1009 (0.00%)  1/1009 (0.10%) 
Enterocolitis infectious  1/1009 (0.10%)  0/1009 (0.00%) 
Exanthema subitum  0/1009 (0.00%)  3/1009 (0.30%) 
Eye infection  0/1009 (0.00%)  1/1009 (0.10%) 
Fungal infection  1/1009 (0.10%)  0/1009 (0.00%) 
Gastric infection  0/1009 (0.00%)  1/1009 (0.10%) 
Gastroenteritis  42/1009 (4.16%)  36/1009 (3.57%) 
Gastroenteritis adenovirus  1/1009 (0.10%)  0/1009 (0.00%) 
Gastroenteritis norovirus  8/1009 (0.79%)  0/1009 (0.00%) 
Gastroenteritis rotavirus  3/1009 (0.30%)  9/1009 (0.89%) 
Gastroenteritis salmonella  0/1009 (0.00%)  1/1009 (0.10%) 
Gastroenteritis viral  1/1009 (0.10%)  1/1009 (0.10%) 
Gastrointestinal infection  2/1009 (0.20%)  2/1009 (0.20%) 
Haemophilus infection  1/1009 (0.10%)  1/1009 (0.10%) 
Incision site abscess  1/1009 (0.10%)  0/1009 (0.00%) 
Infection  8/1009 (0.79%)  15/1009 (1.49%) 
Influenza  1/1009 (0.10%)  0/1009 (0.00%) 
Klebsiella infection  1/1009 (0.10%)  0/1009 (0.00%) 
Laryngitis  3/1009 (0.30%)  3/1009 (0.30%) 
Lobar pneumonia  1/1009 (0.10%)  0/1009 (0.00%) 
Lower respiratory tract infection  7/1009 (0.69%)  6/1009 (0.59%) 
Lower respiratory tract infection viral  1/1009 (0.10%)  0/1009 (0.00%) 
Lung infection  9/1009 (0.89%)  7/1009 (0.69%) 
Mediastinitis  2/1009 (0.20%)  1/1009 (0.10%) 
Meningitis  1/1009 (0.10%)  0/1009 (0.00%) 
Metapneumovirus infection  1/1009 (0.10%)  0/1009 (0.00%) 
Moraxella infection  1/1009 (0.10%)  1/1009 (0.10%) 
Nasopharyngitis  0/1009 (0.00%)  2/1009 (0.20%) 
Nosocomial infection  5/1009 (0.50%)  1/1009 (0.10%) 
Oral candidiasis  1/1009 (0.10%)  0/1009 (0.00%) 
Oral herpes  1/1009 (0.10%)  0/1009 (0.00%) 
Orchitis  0/1009 (0.00%)  1/1009 (0.10%) 
Otitis externa  0/1009 (0.00%)  1/1009 (0.10%) 
Otitis media  3/1009 (0.30%)  9/1009 (0.89%) 
Otitis media acute  1/1009 (0.10%)  1/1009 (0.10%) 
Parainfluenza virus infection  0/1009 (0.00%)  1/1009 (0.10%) 
Pharyngitis  2/1009 (0.20%)  5/1009 (0.50%) 
Pneumococcal sepsis  0/1009 (0.00%)  1/1009 (0.10%) 
Pneumocystitis jiroveci infection  0/1009 (0.00%)  1/1009 (0.10%) 
Pneumonia  30/1009 (2.97%)  38/1009 (3.77%) 
Pneumonia bacterial  1/1009 (0.10%)  0/1009 (0.00%) 
Pneumonia klebsiella  1/1009 (0.10%)  1/1009 (0.10%) 
Pneumonia respiratory syncytial viral  0/1009 (0.00%)  2/1009 (0.20%) 
Pneumonia streptococcal  1/1009 (0.10%)  1/1009 (0.10%) 
Pneumonia viral  1/1009 (0.10%)  0/1009 (0.00%) 
Post procedural infection  3/1009 (0.30%)  14/1009 (1.39%) 
Post procedural pneumonia  1/1009 (0.10%)  0/1009 (0.00%) 
Post procedural sepsis  0/1009 (0.00%)  2/1009 (0.20%) 
Postoperative wound infection  6/1009 (0.59%)  4/1009 (0.40%) 
Pseudomonas infection  3/1009 (0.30%)  3/1009 (0.30%) 
Pyelonephritis  2/1009 (0.20%)  1/1009 (0.10%) 
Respiratory syncytial virus bronchiolitis  5/1009 (0.50%)  17/1009 (1.68%) 
Respiratory syncytial virus infection  4/1009 (0.40%)  5/1009 (0.50%) 
Respiratory tract infection  19/1009 (1.88%)  19/1009 (1.88%) 
Respiratory tract infection bacterial  1/1009 (0.10%)  1/1009 (0.10%) 
Respiratory tract infection viral  3/1009 (0.30%)  2/1009 (0.20%) 
Rhinitis  2/1009 (0.20%)  2/1009 (0.20%) 
Rotavirus infection  1/1009 (0.10%)  4/1009 (0.40%) 
Sepsis  23/1009 (2.28%)  24/1009 (2.38%) 
Septic shock  0/1009 (0.00%)  2/1009 (0.20%) 
Serratia infection  1/1009 (0.10%)  0/1009 (0.00%) 
Skin infection  1/1009 (0.10%)  0/1009 (0.00%) 
Staphylococcal infection  2/1009 (0.20%)  3/1009 (0.30%) 
Staphylococcal sepsis  2/1009 (0.20%)  2/1009 (0.20%) 
Stenotrophomonas infection  1/1009 (0.10%)  0/1009 (0.00%) 
Systemic candida  1/1009 (0.10%)  0/1009 (0.00%) 
Tonsillitis  2/1009 (0.20%)  2/1009 (0.20%) 
Tracheitis  2/1009 (0.20%)  5/1009 (0.50%) 
Tracheobronchitis  1/1009 (0.10%)  0/1009 (0.00%) 
Tracheostomy infection  1/1009 (0.10%)  0/1009 (0.00%) 
Upper respiratory tract infection  25/1009 (2.48%)  23/1009 (2.28%) 
Urinary tract infection  31/1009 (3.07%)  36/1009 (3.57%) 
Urinary tract infection bacterial  2/1009 (0.20%)  0/1009 (0.00%) 
Urosepsis  1/1009 (0.10%)  0/1009 (0.00%) 
Varicella  2/1009 (0.20%)  1/1009 (0.10%) 
Viral infection  8/1009 (0.79%)  3/1009 (0.30%) 
Viral tonsillitis  1/1009 (0.10%)  0/1009 (0.00%) 
Viral upper respiratory tract infection  1/1009 (0.10%)  0/1009 (0.00%) 
Wound infection  5/1009 (0.50%)  3/1009 (0.30%) 
Wound infection fungal  1/1009 (0.10%)  0/1009 (0.00%) 
Wound infection staphylococcal  0/1009 (0.00%)  1/1009 (0.10%) 
Injury, poisoning and procedural complications     
Cardiac pacemaker malfunction  1/1009 (0.10%)  0/1009 (0.00%) 
Investigations     
Clostridium difficile toxin test  1/1009 (0.10%)  0/1009 (0.00%) 
Respiratory syncytial virus test positive  1/1009 (0.10%)  1/1009 (0.10%) 
Metabolism and nutrition disorders     
Dehydration  0/1009 (0.00%)  1/1009 (0.10%) 
Nervous system disorders     
Febrile convulsion  2/1009 (0.20%)  0/1009 (0.00%) 
Syncope  1/1009 (0.10%)  0/1009 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  0/1009 (0.00%)  1/1009 (0.10%) 
Lung consolidation  4/1009 (0.40%)  0/1009 (0.00%) 
Pneumonia aspiration  1/1009 (0.10%)  0/1009 (0.00%) 
Respiratory arrest  1/1009 (0.10%)  0/1009 (0.00%) 
Respiratory distress  1/1009 (0.10%)  0/1009 (0.00%) 
Pulmonary arterial hypertension  0/1009 (0.00%)  1/1009 (0.10%) 
Skin and subcutaneous tissue disorders     
Hangnail  0/1009 (0.00%)  1/1009 (0.10%) 
Vascular disorders     
Haemodynamic instability  1/1009 (0.10%)  0/1009 (0.00%) 
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Palivizumab-treated Subjects (CASES) Non-palivizumab-treated Subjects (CONTROLS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Only serious adverse events of infection and arrhythmia as well as deaths were collected in this study. The criterion for non-inferiority was not met for death, most likely because the reported mortality rates were lower than expected in both groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Andrew L. Campbell, M.D., Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01075178     History of Changes
Other Study ID Numbers: M03-681
First Submitted: February 23, 2010
First Posted: February 25, 2010
Results First Submitted: January 28, 2011
Results First Posted: February 24, 2011
Last Update Posted: March 23, 2011