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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infection; Premature Birth; Bronchopulmonary Dysplasia; Congenital Heart Disease
• Interventions: Biological: palivizumab

• Registration Number: NCT01006629
• Lead Sponsor: Abbott

Brief Summary

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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Results First Submitted: 2011-04-29
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-21
• Last Update Submitted: 2011-06-21
• Results First Posted: 2011-07-19
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
palivizumab	palivizumab	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	Through 30 days following the last injection of palivizumab	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.
Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)	Through 30 days following the last injection of palivizumab	Number of subjects experiencing an RSV hospitalization

Secondary Outcome Measures

Name	Time	Method
Total Number of RSV Hospitalization Days	Through 30 days following the last injection of palivizumab	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.
Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement	Through 30 days following the last injection of palivizumab	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.
Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization	Through 30 days following the last injection of palivizumab	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.
Total Days of RSV ICU Stay	Through 30 days following the last injection of palivizumab	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.
Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization	Through 30 days following the last injection of palivizumab	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.
Total Days of Mechanical Ventilation During RSV Hospitalization	Through 30 days following the last injection of palivizumab	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.

Trial Locations

Locations (19)

Site Ref # / Investigator 22699; 🇷🇺 Ivanovo, Russian Federation

Site Ref # / Investigator 24025; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 15781; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 22686; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 15747; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 22683; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 22693; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 15722; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 15746; 🇷🇺 Tomsk, Russian Federation

Site Ref # / Investigator 22685; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 15748; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 15782; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 22692; 🇷🇺 Saint Petersburg, Russian Federation

Site Ref # / Investigator 15745; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 22694; 🇷🇺 Kazan, Russian Federation

Site Ref # / Investigator 22696; 🇷🇺 Novosibirsk, Russian Federation

Site Ref # / Investigator 24023; 🇷🇺 Novosibirsk, Russian Federation

Site Ref # / Investigator 15744; 🇷🇺 Moscow, Russian Federation

Site Ref # / Investigator 24022; 🇷🇺 Moscow, Russian Federation