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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006629
• Other study ID #: W10-664
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 2, 2009
• Last updated: June 21, 2011
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationRussia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Communicable Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Infection
• Premature Birth
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Biological:
• palivizumab
palivizumab 15 mg/kg intramuscularly

Locations

Country	Name	City	State
Russian Federation	Site Ref # / Investigator 22699	Ivanovo
Russian Federation	Site Ref # / Investigator 22694	Kazan
Russian Federation	Site Ref # / Investigator 15744	Moscow
Russian Federation	Site Ref # / Investigator 15745	Moscow
Russian Federation	Site Ref # / Investigator 15747	Moscow
Russian Federation	Site Ref # / Investigator 15781	Moscow
Russian Federation	Site Ref # / Investigator 22686	Moscow
Russian Federation	Site Ref # / Investigator 24022	Moscow
Russian Federation	Site Ref # / Investigator 24025	Moscow
Russian Federation	Site Ref # / Investigator 22696	Novosibirsk
Russian Federation	Site Ref # / Investigator 24023	Novosibirsk
Russian Federation	Site Ref # / Investigator 15722	Saint Petersburg
Russian Federation	Site Ref # / Investigator 15748	Saint Petersburg
Russian Federation	Site Ref # / Investigator 15782	Saint Petersburg
Russian Federation	Site Ref # / Investigator 22683	Saint Petersburg
Russian Federation	Site Ref # / Investigator 22685	Saint Petersburg
Russian Federation	Site Ref # / Investigator 22692	Saint Petersburg
Russian Federation	Site Ref # / Investigator 22693	Saint Petersburg
Russian Federation	Site Ref # / Investigator 15746	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   Link