Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01006629
First received: November 2, 2009
Last updated: June 21, 2011
Last verified: June 2011
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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:
|
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:
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).
Exclusion Criteria:
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.
Contacts and Locations
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 22686 | |
| Moscow, Russian Federation, 119991 | |
| Site Ref # / Investigator 24022 | |
| Moscow, Russian Federation, 117198 | |
| Site Ref # / Investigator 15744 | |
| Moscow, Russian Federation, 117931 | |
| Site Ref # / Investigator 15747 | |
| Moscow, Russian Federation, 125412 | |
| Site Ref # / Investigator 15781 | |
| Moscow, Russian Federation, 119991 | |
| Site Ref # / Investigator 15745 | |
| Moscow, Russian Federation, 117997 | |
| Site Ref # / Investigator 24025 | |
| Moscow, Russian Federation, 117997 | |
| 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 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 15748 | |
| Saint Petersburg, Russian Federation, 198205 | |
| Site Ref # / Investigator 15782 | |
| Saint Petersburg, Russian Federation, 198205 | |
| 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 Heart Diseases Respiratory Syncytial Virus Infections Virus Diseases Premature Birth Heart Defects, Congenital Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Cardiovascular Diseases Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Cardiovascular Abnormalities Congenital Abnormalities Palivizumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013