Synagis Russia: A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02968173
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Actual Duration (Months): 8.1

Study Details

Study Description

Brief Summary

This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease [CHD]).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus (RSV)	Drug: Palivizumab	Phase 3

Detailed Description

Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Nov 9, 2016
• Actual Primary Completion Date: Jul 13, 2017
• Actual Study Completion Date: Jul 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children at High Risk of severe RSV Infection A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.	Drug: Palivizumab; Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.; Other Names: Synagis

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With RSV Hospitalization [Approximately 6 months]

   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).

Secondary Outcome Measures

1. Total Number of RSV-Hospitalization Days [Approximately 6 months]

2. Percentage of Participants Who Received Supplemental Oxygen While Hospitalized [Approximately 6 months]

   Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.

3. Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement [Approximately 6 months]

   Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.

4. Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization [Approximately 6 months]

5. Total Days of RSV-ICU Stay [Approximately 6 months]

6. Percentage of Participants Who Received Mechanical Ventilation [Approximately 6 months]

7. Total Days of Mechanical Ventilation During RSV-hospitalization [Approximately 6 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

• Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment

• Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment

• Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage hemodynamically significant CHD

Exclusion Criteria (main exclusion criteria):

• Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days)

• Mechanical ventilation (including continuous positive airway pressure, CPAP) at the time of enrollment

• Life expectancy less than 6 months

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

• Active respiratory illness, or other acute infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Joaquin Valdes, AbbVie

Study Documents (Full-Text)

• Statistical Analysis Plan - Jan 30, 2017
• Study Protocol - May 25, 2016

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02968173
• Other Study ID Numbers: M15-539; 2016-000221-39
• First Posted: Nov 18, 2016
• Last Update Posted: Mar 13, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by AbbVie: Bronchopulmonary dysplasia (BPD); RSV hospitalization; Palivizumab; Immunoprophylaxis; Chronic lung disease (CLD) of prematurity
• Additional relevant MeSH terms: Infections; Virus Diseases; Palivizumab

Study Results

Participant Flow

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 respiratory syncytial virus (RSV) season a participant was enrolled.
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Overall Participants	50
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	6.22 (4.428)
Sex: Female, Male (Count of Participants)
Female	24 48%
Male	26 52%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	50 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	50 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With RSV Hospitalization
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).
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	0.0 0%

2. Secondary Outcome

Title	Total Number of RSV-Hospitalization Days
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

3. Secondary Outcome

Title	Percentage of Participants Who Received Supplemental Oxygen While Hospitalized
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.
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

4. Secondary Outcome

Title	Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
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.
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

5. Secondary Outcome

Title	Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

6. Secondary Outcome

Title	Total Days of RSV-ICU Stay
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

7. Secondary Outcome

Title	Percentage of Participants Who Received Mechanical Ventilation
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

8. Secondary Outcome

Title	Total Days of Mechanical Ventilation During RSV-hospitalization
Time Frame	Approximately 6 months

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Children at High Risk of Severe RSV Infection
Arm/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 participant was enrolled.
Measure Participants	0

Adverse Events

Time Frame	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)
Arm/Group Title	PALIVIZUMAB TEAE Within 30 Days		PALIVIZUMAB TEAE Within 100 Days
Arm/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 participant 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.		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 participant 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.
All Cause Mortality
	PALIVIZUMAB TEAE Within 30 Days		PALIVIZUMAB TEAE Within 100 Days
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	PALIVIZUMAB TEAE Within 30 Days		PALIVIZUMAB TEAE Within 100 Days
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/50 (12%)		6/50 (12%)
Cardiac disorders
Tachycardia paroxysmal	1/50 (2%)		1/50 (2%)
Infections and infestations
Bronchitis	1/50 (2%)		1/50 (2%)
Bronchitis viral	1/50 (2%)		1/50 (2%)
Nasopharyngitis	1/50 (2%)		1/50 (2%)
Pneumonia	1/50 (2%)		1/50 (2%)
Respiratory tract infection viral	1/50 (2%)		1/50 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma	1/50 (2%)		1/50 (2%)
Other (Not Including Serious) Adverse Events
	PALIVIZUMAB TEAE Within 30 Days		PALIVIZUMAB TEAE Within 100 Days
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.