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

NCT01006629 | Completed Phase 2 Results

• 1 other identifier: W10-664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 19

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.

Conditions

Respiratory Syncytial Virus Infection; Premature Birth; Bronchopulmonary Dysplasia; Congenital Heart Disease

Keywords

Efficacy of palivizumab; Respiratory syncytial virus (RSV) infection; Prevention of severe RSV infection; Preterm infants; Infants with bronchopulmonary dysplasia; Infants with hemodynamically significant congenital heart disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Total Number of RSV Hospitalization Days

  Through 30 days following the last injection of palivizumab

• Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement

  Through 30 days following the last injection of palivizumab

• Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization

  Through 30 days following the last injection of palivizumab

• Total Days of RSV ICU Stay

  Through 30 days following the last injection of palivizumab

• Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization

  Through 30 days following the last injection of palivizumab

Study Arms (1)

palivizumab

EXPERIMENTAL

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

Biological: palivizumab

Interventions

palivizumab BIOLOGICAL

palivizumab 15 mg/kg intramuscularly

Also known as: ABT-315 (MEDI-493), Synagis 15 mg/kg intramuscularly

palivizumab

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must meet all of the following criteria to be enrolled into the study:
• 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.
• Informed Consent Form signed by parent(s).

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible for the study:
• 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.
• Active respiratory illness, or other acute infection.
• Known renal impairment, as determined by the investigator.
• Known hepatic impairment, as determined by the investigator.
• History of seizures (except neonatal seizures).
• Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
• Known immunodeficiency, as determined by the investigator.
• Allergy to immunoglobulin products.
• 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).
• Participation in another clinical trial within 30 days prior to enrollment.
• Previous enrollment in this trial.
• For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Sponsors & Collaborators

• Abbott: lead

Study Sites (19)

Site Ref # / Investigator 22699

Ivanovo, 153731, Russia

Location

Site Ref # / Investigator 22694

Kazan', 420012, Russia

Location

Site Ref # / Investigator 24022

Moscow, 117198, Russia

Location

Site Ref # / Investigator 15744

Moscow, 117931, Russia

Location

Site Ref # / Investigator 15745

Moscow, 117997, Russia

Location

Site Ref # / Investigator 24025

Moscow, 117997, Russia

Location

Site Ref # / Investigator 15781

Moscow, 119991, Russia

Location

Site Ref # / Investigator 22686

Moscow, 119991, Russia

Location

Site Ref # / Investigator 15747

Moscow, 125412, Russia

Location

Site Ref # / Investigator 22696

Novosibirsk, 630091, Russia

Location

Site Ref # / Investigator 24023

Novosibirsk, 630091, Russia

Location

Site Ref # / Investigator 22692

Saint Petersburg, 193312, Russia

Location

Site Ref # / Investigator 22683

Saint Petersburg, 194100, Russia

Location

Site Ref # / Investigator 22693

Saint Petersburg, 194291, Russia

Location

Site Ref # / Investigator 22685

Saint Petersburg, 196650, Russia

Location

Site Ref # / Investigator 15722

Saint Petersburg, 197022, Russia

Location

Site Ref # / Investigator 15748

Saint Petersburg, 198205, Russia

Location

Site Ref # / Investigator 15782

Saint Petersburg, 198205, Russia

Location

Site Ref # / Investigator 15746

Tomsk, 634012, Russia

Location

Related Publications (1)

• 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.

  PMID: 22943074 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Premature Birth; Bronchopulmonary Dysplasia; Heart Defects, Congenital; Infections

Interventions

Palivizumab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study had no control group; relative comparisons are only possible with current product information for palivizumab. No RSV hospitalizations occurred during the study; therefore, secondary outcome measures could not be evaluated.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Konstantin M Gudkov, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 19, 2011
• Results First Posted: July 19, 2011

Record last verified: 2011-06

Locations

RU (19)