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 (Synagis Russia)

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

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]).

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Drug: Palivizumab

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With RSV Hospitalization	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).	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of RSV-Hospitalization Days		Approximately 6 months
Percentage of Participants Who Received Supplemental Oxygen While Hospitalized	Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.	Approximately 6 months
Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement	Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.	Approximately 6 months
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization		Approximately 6 months
Total Days of RSV-ICU Stay		Approximately 6 months
Percentage of Participants Who Received Mechanical Ventilation		Approximately 6 months
Total Days of Mechanical Ventilation During RSV-hospitalization		Approximately 6 months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Joaquin Valdes, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2016
• Primary Completion (ACTUAL): July 13, 2017
• Study Completion (ACTUAL): July 13, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (ESTIMATE): November 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Palivizumab; Bronchopulmonary dysplasia (BPD); Immunoprophylaxis; RSV hospitalization; Chronic lung disease (CLD) of prematurity
• Additional Relevant MeSH Terms: Infections; Virus Diseases; Anti-Infective Agents; Antiviral Agents; Palivizumab
• Other Study ID Numbers: M15-539; 2016-000221-39 (EUDRACT_NUMBER)