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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968173
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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 : November 9, 2016
Actual Primary Completion Date : July 13, 2017
Actual Study Completion Date : July 13, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Palivizumab

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 Name: Synagis




Primary Outcome Measures :
  1. Percentage of Participants With RSV Hospitalization [ Time Frame: 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 [ Time Frame: Approximately 6 months ]
  2. Percentage of Participants Who Received Supplemental Oxygen While Hospitalized [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approximately 6 months ]
  5. Total Days of RSV-ICU Stay [ Time Frame: Approximately 6 months ]
  6. Percentage of Participants Who Received Mechanical Ventilation [ Time Frame: Approximately 6 months ]
  7. Total Days of Mechanical Ventilation During RSV-hospitalization [ Time Frame: Approximately 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968173


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Joaquin Valdes AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Statistical Analysis Plan  [PDF] January 30, 2017
Study Protocol  [PDF] May 25, 2016


Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02968173    
Other Study ID Numbers: M15-539
2016-000221-39 ( EudraCT Number )
First Posted: November 18, 2016    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: July 2017
Keywords provided by AbbVie:
Bronchopulmonary dysplasia (BPD)
RSV hospitalization
Palivizumab
Immunoprophylaxis
Chronic lung disease (CLD) of prematurity
Additional relevant MeSH terms:
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Infection
Virus Diseases
Palivizumab
Antiviral Agents
Anti-Infective Agents