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

NCT ID: NCT01006629

Last Updated: 2011-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-07-31

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]).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

palivizumab

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

Group Type: EXPERIMENTAL

palivizumab

Intervention Type: BIOLOGICAL

palivizumab 15 mg/kg intramuscularly

Interventions

palivizumab

palivizumab 15 mg/kg intramuscularly

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-315 (MEDI-493); Synagis 15 mg/kg intramuscularly

Eligibility Criteria

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.

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Laboratories LLC Russia

Principal Investigators

Konstantin M Gudkov, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Ref # / Investigator 22699

Ivanovo, , Russia

Site Ref # / Investigator 22694

Kazan', , Russia

Site Ref # / Investigator 24022

Moscow, , Russia

Site Ref # / Investigator 15744

Moscow, , Russia

Site Ref # / Investigator 15745

Moscow, , Russia

Site Ref # / Investigator 24025

Moscow, , Russia

Site Ref # / Investigator 15781

Moscow, , Russia

Site Ref # / Investigator 22686

Moscow, , Russia

Site Ref # / Investigator 15747

Moscow, , Russia

Site Ref # / Investigator 22696

Novosibirsk, , Russia

Site Ref # / Investigator 24023

Novosibirsk, , Russia

Site Ref # / Investigator 22692

Saint Petersburg, , Russia

Site Ref # / Investigator 22683

Saint Petersburg, , Russia

Site Ref # / Investigator 22693

Saint Petersburg, , Russia

Site Ref # / Investigator 22685

Saint Petersburg, , Russia

Site Ref # / Investigator 15722

Saint Petersburg, , Russia

Site Ref # / Investigator 15748

Saint Petersburg, , Russia

Site Ref # / Investigator 15782

Saint Petersburg, , Russia

Site Ref # / Investigator 15746

Tomsk, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 22943074 (View on PubMed)

Related Links

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=23151&CFID

Related Info

Other Identifiers

W10-664

Identifier Type: -

Identifier Source: org_study_id