Clinical Trial Results:
A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
Summary
|
|
EudraCT number |
2016-000221-39 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Jul 2017
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
25 Jan 2018
|
First version publication date |
25 Jan 2018
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
M15-539
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02968173 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
AbbVie Deutschland GmbH & Co.KG
|
||
Sponsor organisation address |
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
|
||
Public contact |
Joaquin Valdes MD, AbbVie, joaquin.m.valdes@abbvie.com
|
||
Scientific contact |
Joaquin Valdes MD, AbbVie, joaquin.m.valdes@abbvie.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 Jul 2017
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
13 Jul 2017
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To collect further data on safety and effectiveness of the liquid formulation of palivizumab (Synagis®) administered as monthly intramuscular injections among preterm infants, infants with chronic lung disease (CLD) of prematurity and infants with hemodynamically significant congenital heart disease (CHD)
|
||
Protection of trial subjects |
Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Nov 2016
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belarus: 7
|
||
Country: Number of subjects enrolled |
Russian Federation: 43
|
||
Worldwide total number of subjects |
50
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
50
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||
Recruitment
|
|||||||||||
Recruitment details |
- | ||||||||||
Pre-assignment
|
|||||||||||
Screening details |
Subjects were screened for adherence in inclusion/exclusion criteria at The Baseline (Enrollment) Visit. | ||||||||||
Period 1
|
|||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Arms
|
|||||||||||
Arm title
|
Children at High Risk of Severe RSV Infection | ||||||||||
Arm description |
A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
palivizumab
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
Synagis
|
||||||||||
Pharmaceutical forms |
Solution for injection
|
||||||||||
Routes of administration |
Intramuscular use
|
||||||||||
Dosage and administration details |
All subjects were to receive 15 mg/kg of the liquid formulation of palivizumab administered by IM injection by the research staff or designee (health care professional) at the study site every 30 days for a minimum of 3 doses and a maximum of 5 doses.
|
||||||||||
|
|
||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Children at High Risk of Severe RSV Infection
|
|||||||||||||||||||||||||||||||||
Reporting group description |
A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. | |||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Children at High Risk of Severe RSV Infection
|
||
Reporting group description |
A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. |
|
|||||||||
End point title |
Percentage of Subjects With RSV Hospitalization [1] | ||||||||
End point description |
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Approximately 6 months
|
||||||||
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 statistics are presented, per protocol. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Total Number of RSV-Hospitalization Days | ||||||
End point description |
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
Approximately 6 months
|
||||||
|
|||||||
Notes [2] - no subjects experienced an RSV hospitalization during the study |
|||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of Subjects Who Received Supplemental Oxygen While Hospitalized | ||||||||
End point description |
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Approximately 6 months
|
||||||||
|
|||||||||
Notes [3] - no subjects experienced an RSV hospitalization during the study |
|||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement | ||||||
End point description |
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
Approximately 6 months
|
||||||
|
|||||||
Notes [4] - no subjects experienced an RSV hospitalization during the study |
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization | ||||||
End point description |
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
Approximately 6 months
|
||||||
|
|||||||
Notes [5] - no subjects experienced an RSV hospitalization during the study |
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Total Days of RSV-ICU Stay | ||||||
End point description |
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
Approximately 6 months
|
||||||
|
|||||||
Notes [6] - no subjects experienced an RSV hospitalization during the study |
|||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of Subjects Who Received Mechanical Ventilation | ||||||||
End point description |
All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Approximately 6 months
|
||||||||
|
|||||||||
Notes [7] - no subjects experienced an RSV hospitalization during the study |
|||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Total Days of Mechanical Ventilation During RSV-hospitalization | ||||||
End point description |
All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
Approximately 6 months
|
||||||
|
|||||||
Notes [8] - no subjects experienced an RSV hospitalization during the study |
|||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first dose of study treatment through the last prophylaxis visit (up to Day 120 [±5 days]) + 30 days (+5 days) and 100 days (+5 days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PALIVIZUMAB TEAE Within 30 Days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. Treatment-emergent adverse events (TEAEs) are defined as those that began after the first dose of study drug but within 30 days (+ 30 day assessment period) after the last dose of study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PALIVIZUMAB TEAE Within 100 Days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. TEAEs are defined as those that began after the first dose of study drug but within 100 days (+ 100 day assessment period) after the last dose of study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No subjects had a non-serious adverse event above the 5% threshold. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
25 May 2016 |
Protocol Amendment 1 modified the study objective to reflect the large amount of data already available for the study drug. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |