Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Congenital Heart Disease; Bronchopulmonary Dysplasia; Respiratory Syncytial Virus Infection
• Intervention / Treatment: Biological: palivizumab

Detailed Description

A prospective, multicenter, open-label, non-comparative study of safety and efficacy of palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe lower respiratory tract respiratory syncytial virus infection in 100 Russian children of 2 years of age and less in high-risk populations (preterm infants [less than or equal to 35 weeks gestational age], infants with bronchopulmonary dysplasia [BPD], and infants with hemodynamically significant congenital heart disease [HSCHD]).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Ivanovo, Russian Federation, 153731
    • Site Ref # / Investigator 22699
  • Kazan, Russian Federation, 420012
    • Site Ref # / Investigator 22694
  • Moscow, Russian Federation, 117198
    • Site Ref # / Investigator 24022
  • Moscow, Russian Federation, 117931
    • Site Ref # / Investigator 15744
  • Moscow, Russian Federation, 117997
    • Site Ref # / Investigator 15745
  • Moscow, Russian Federation, 117997
    • Site Ref # / Investigator 24025
  • Moscow, Russian Federation, 119991
    • Site Ref # / Investigator 15781
  • Moscow, Russian Federation, 119991
    • Site Ref # / Investigator 22686
  • Moscow, Russian Federation, 125412
    • Site Ref # / Investigator 15747
  • Novosibirsk, Russian Federation, 630091
    • Site Ref # / Investigator 22696
  • Novosibirsk, Russian Federation, 630091
    • Site Ref # / Investigator 24023
  • Saint Petersburg, Russian Federation, 193312
    • Site Ref # / Investigator 22692
  • Saint Petersburg, Russian Federation, 194100
    • Site Ref # / Investigator 22683
  • Saint Petersburg, Russian Federation, 194291
    • Site Ref # / Investigator 22693
  • Saint Petersburg, Russian Federation, 196650
    • Site Ref # / Investigator 22685
  • Saint Petersburg, Russian Federation, 197022
    • Site Ref # / Investigator 15722
  • Saint Petersburg, Russian Federation, 198205
    • Site Ref # / Investigator 15748
  • Saint Petersburg, Russian Federation, 198205
    • Site Ref # / Investigator 15782
  • Tomsk, Russian Federation, 634012
    • Site Ref # / Investigator 15746

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled into the study:

1. Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

   • Infants born at less than or equal to 35 weeks gestational age AND are less than or equal to 6 months of age at enrollment
   • Infants less than or equal to 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (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 less than or equal to 24 months of age at enrollment with hemodynamically significant congenital heart disease, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (greater than or equal to 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage congenital heart disease. Children with the following conditions are not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosis, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone.
2. Informed Consent Form signed by parent(s).

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for the study:

1. Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).
2. Mechanical ventilation (including continuous positive airway pressure [CPAP]) at the time of enrollment.
3. Life expectancy less than 6 months.
4. Active respiratory illness, or other acute infection.
5. Known renal impairment, as determined by the investigator.
6. Known hepatic impairment, as determined by the investigator.
7. History of seizures (except neonatal seizures).
8. Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
9. Known immunodeficiency, as determined by the investigator.
10. Allergy to immunoglobulin products.
11. Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin).
12. Participation in another clinical trial within 30 days prior to enrollment.
13. Previous enrollment in this trial.
14. For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: palivizumab; palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections	Biological: palivizumab; palivizumab 15 mg/kg intramuscularly; Other Names: ABT-315 (MEDI-493); Synagis 15 mg/kg intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events	Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.	Through 30 days following the last injection of palivizumab
Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)	Number of subjects experiencing an RSV hospitalization	Through 30 days following the last injection of palivizumab

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of RSV Hospitalization Days	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab
Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab
Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization	Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab
Total Days of RSV ICU Stay	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab
Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab
Total Days of Mechanical Ventilation During RSV Hospitalization	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.	Through 30 days following the last injection of palivizumab

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Konstantin M Gudkov, MD, Abbott

Publications and helpful links

General Publications

• Turti TV, Baibarina EN, Degtiareva EA, Keshishyan ES, Lobzin YV, Namazova-capital VE, Cyrillicaranova LS, Prodeus AP, Gudkov KM, Kruglova AI, Schulz GA, Notario GF. A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation. BMC Res Notes. 2012 Sep 4;5:484. doi: 10.1186/1756-0500-5-484.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 19, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Preterm infants; Efficacy of palivizumab; Respiratory syncytial virus (RSV) infection; Prevention of severe RSV infection; Infants with bronchopulmonary dysplasia; Infants with hemodynamically significant congenital heart disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; RNA Virus Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Congenital Abnormalities; Infant, Newborn, Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Cardiovascular Abnormalities; Infant, Premature, Diseases; Pneumovirus Infections; Ventilator-Induced Lung Injury; Heart Diseases; Infections; Communicable Diseases; Virus Diseases; Premature Birth; Heart Defects, Congenital; Respiratory Syncytial Virus Infections; Bronchopulmonary Dysplasia; Anti-Infective Agents; Antiviral Agents; Palivizumab
• Other Study ID Numbers: W10-664