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

NCT02968173 | Completed Phase 3 Results

• 2 other identifiers: M15-5392016-000221-39
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 \[CHD\]).

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Bronchopulmonary dysplasia (BPD); RSV hospitalization; Palivizumab; Immunoprophylaxis; Chronic lung disease (CLD) of prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total Number of RSV-Hospitalization Days

  Approximately 6 months

• Percentage of Participants Who Received Supplemental Oxygen While Hospitalized

  Approximately 6 months

• Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement

  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

Study Arms (1)

Children at High Risk of severe RSV Infection

EXPERIMENTAL

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

Interventions

Palivizumab 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.

Also known as: Synagis

Children at High Risk of severe RSV Infection

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Congenital chloride diarrhea

Interventions

Palivizumab

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Joaquin Valdes

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: November 9, 2016
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2017-07