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

Respiratory Syncytial Virus (RSV) Clinical Trial

— Synagis Russia  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968173
• Other study ID #: M15-539
• Secondary ID: 2016-000221-39
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2016
• Last updated: February 9, 2018
• Start date: November 9, 2016
• Est. completion date: July 13, 2017

Study information

• Verified date: July 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Number of RSV-Hospitalization Days		Approximately 6 months
Secondary	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
Secondary	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
Secondary	Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization		Approximately 6 months
Secondary	Total Days of RSV-ICU Stay		Approximately 6 months
Secondary	Percentage of Participants Who Received Mechanical Ventilation		Approximately 6 months
Secondary	Total Days of Mechanical Ventilation During RSV-hospitalization		Approximately 6 months

External Links

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