Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01006629
First received: November 2, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Respiratory Syncytial Virus Infection
Premature Birth
Bronchopulmonary Dysplasia
Congenital Heart Disease
Biological: palivizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    Number of subjects experiencing an RSV hospitalization


Secondary Outcome Measures:
  • Total Number of RSV Hospitalization Days [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Through 30 days following the last injection of palivizumab ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: palivizumab
palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Biological: palivizumab
palivizumab 15 mg/kg intramuscularly
Other Names:
  • ABT-315 (MEDI-493)
  • palivizumab
  • Synagis 15 mg/kg intramuscularly

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]).

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006629

Locations
Russian Federation
Site Ref # / Investigator 22699
Ivanovo, Russian Federation, 153731
Site Ref # / Investigator 22694
Kazan, Russian Federation, 420012
Site Ref # / Investigator 24025
Moscow, Russian Federation, 117997
Site Ref # / Investigator 15744
Moscow, Russian Federation, 117931
Site Ref # / Investigator 15745
Moscow, Russian Federation, 117997
Site Ref # / Investigator 15781
Moscow, Russian Federation, 119991
Site Ref # / Investigator 22686
Moscow, Russian Federation, 119991
Site Ref # / Investigator 24022
Moscow, Russian Federation, 117198
Site Ref # / Investigator 15747
Moscow, Russian Federation, 125412
Site Ref # / Investigator 22696
Novosibirsk, Russian Federation, 630091
Site Ref # / Investigator 24023
Novosibirsk, Russian Federation, 630091
Site Ref # / Investigator 15722
Saint Petersburg, Russian Federation, 197022
Site Ref # / Investigator 15748
Saint Petersburg, Russian Federation, 198205
Site Ref # / Investigator 15782
Saint Petersburg, Russian Federation, 198205
Site Ref # / Investigator 22683
Saint Petersburg, Russian Federation, 194100
Site Ref # / Investigator 22685
Saint Petersburg, Russian Federation, 196650
Site Ref # / Investigator 22692
Saint Petersburg, Russian Federation, 193312
Site Ref # / Investigator 22693
Saint Petersburg, Russian Federation, 194291
Site Ref # / Investigator 15746
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Abbott
Investigators
Study Director: Konstantin M Gudkov, MD Abbott
  More Information

Additional Information:
No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konstantin Gudkov, Clinical Research Project Manager, Abbott Laboratories LLC Russia
ClinicalTrials.gov Identifier: NCT01006629     History of Changes
Other Study ID Numbers: W10-664
Study First Received: November 2, 2009
Results First Received: April 29, 2011
Last Updated: June 21, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Keywords provided by Abbott:
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

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Communicable Diseases
Heart Defects, Congenital
Heart Diseases
Infection
Premature Birth
Respiratory Syncytial Virus Infections
Virus Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Mononegavirales Infections
Obstetric Labor Complications
Obstetric Labor, Premature
Paramyxoviridae Infections
Pneumovirus Infections
Pregnancy Complications
RNA Virus Infections
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Palivizumab
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014