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

NCT ID: NCT02968173

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-09
• Study Completion Date: 2017-07-13

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]).

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.

Conditions

Respiratory Syncytial Virus (RSV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palivizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Synagis

Eligibility Criteria

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

• 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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joaquin Valdes

Role: STUDY_DIRECTOR

AbbVie

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

Other Identifiers

2016-000221-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-539

Identifier Type: -

Identifier Source: org_study_id