Clinical Trial Results:
A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation
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Summary
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EudraCT number |
2014-004527-42 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Jul 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Apr 2016
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First version publication date |
14 Jun 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
W10-664
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01006629 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AbbVie
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Sponsor organisation address |
1 North Waukegan Road, North Chicago, IL, United States, 60064
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Public contact |
Global Medical Information, AbbVie, 001 800-633-9110,
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Scientific contact |
Global Medical Information, AbbVie, 001 800-633-9110,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Jul 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Jul 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
100 Russian children of 2 years of age and less in high-risk populations (preterm infants [less than or equal to 35 weeks gestational age], infants with bronchopulmonary dysplasia [BPD], and infants with hemodynamically significant congenital heart disease [HSCHD]) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.
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Protection of trial subjects |
The investigator or his/her representative explained the nature of the study to the subject's parent(s), and answered all questions regarding this study. Prior to any study-related procedures being performed on the subject, the Informed Consent Form was reviewed, signed and dated by the subject's parent(s), the person who administered the informed consent and an impartial witness (a person not involved in the study team at the site and not an Abbott employee). For subjects with two parents, at least one had to sign the consent, stating that the other parent did not object. Participant cards were provided to the subject's parent(s) after the informed consent process, providing contact information for the investigator as well as additional relevant information regarding their child's participation in the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Russian Federation: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
1
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Infants and toddlers (28 days-23 months) |
99
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled into the study in 3 geographic areas of the Russian Federation. Recruitment began in November 2009 and ended in December 2009. Subjects at high risk of severe RSV infection (including preterm infants, infants with BPD, and infants with HSCHD) were identified as candidates for the study on the basis of routine assessments. | ||||||||||||||
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Pre-assignment
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Screening details |
Screening assessments were conducted at Visit 1 (Day 0) prior to enrollment and study drug administration. | ||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Palivizumab | ||||||||||||||
Arm description |
Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Palivizumab
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Investigational medicinal product code |
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Other name |
ABT-315 (MEDI-493), Synagis 15 mg/kg intramuscularly
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
palivizumab 15 mg/kg intramuscularly
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Baseline characteristics reporting groups
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Reporting group title |
Palivizumab
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Reporting group description |
Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Palivizumab
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Reporting group description |
Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections | ||
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End point title |
Frequency of adverse events [1] | ||||||||
End point description |
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.
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End point type |
Primary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive data were summarized for this endpoint per protocol. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of hospitalizations due to respiratory syncytial virus (RSV) [2] | ||||||||
End point description |
Number of subjects experiencing an RSV hospitalization
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End point type |
Primary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive data were summarized for this endpoint per protocol. |
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End point title |
Total number of RSV hospitalization days | ||||||||
End point description |
All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [3] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Total RSV hospitalization days with increased supplemental oxygen requirement | ||||||||
End point description |
All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [4] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of intensive care unit (ICU) admissions during RSV hospitalization | ||||||||
End point description |
Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [5] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Total days of RSV ICU stay | ||||||||
End point description |
All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [6] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization | ||||||||
End point description |
All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [7] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Total Days of Mechanical Ventilation During RSV Hospitalization | ||||||||
End point description |
All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
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End point type |
Secondary
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End point timeframe |
Through 30 days following the last injection of palivizumab
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| Notes [8] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From date of first dose of study drug through 100 days after the last dose of study drug
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
Palivizumab
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Reporting group description |
Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 May 2009 |
The purpose of this amendment is to change the first month of enrollment from October to November as well as to clarify to several Inclusion/Exclusion Criteria, Prior and Concomitant therapies and also correct any typographical errors, and make several administrative changes/additions. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| This study had no control group; relative comparisons are only possible with current product information for palivizumab. No RSV hospitalizations occurred during the study; therefore, secondary outcome measures could not be evaluated. | |||
