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

Brief Title

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

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

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 Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Frequency of Adverse Events

Secondary Outcome

 Total Number of RSV Hospitalization Days

Condition

Respiratory Syncytial Virus Infection

Intervention

palivizumab

Study Arms / Comparison Groups

 palivizumab

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

100

Start Date

November 2009

Completion Date

July 2010

Primary Completion Date

April 2010

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.
      

Gender

All

Ages

N/A - 2 Years

Accepts Healthy Volunteers

No

Contacts

Konstantin M Gudkov, MD, , 

Location Countries

Russian Federation

Location Countries

Russian Federation

NCT ID

NCT01006629

Organization ID

W10-664

Study Sponsor

Abbott

Study Sponsor

Konstantin M Gudkov, MD, Study Director, Abbott

Verification Date

June 2011