Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children.
- Conditions
- Severe Respiratory Syncytial Virus Infection (RSV)MedDRA version: 17.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004527-42-Outside-EU/EEA
- Lead Sponsor
- Abbott Laboratories LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 100
1. Infants at high risk of severe RSV infection fulfilling at least one of the following:
a. Infants born = 35 weeks gestational age AND = 6 months of age at
enrollment;
b. Infants = 24 months of age at enrollment AND with a diagnosis of BPD
(defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) any time within 6 months prior to enrollment;
c. Infants = 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, not operated or partially corrected. Infants with acyanotic cardiac lesions had to have pulmonary hypertension (= 40 mm Hg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage CHD.
Infants with the following conditions were not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosus, infants with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone.
2. Informed Consent Form signed by parent(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study was to describe the safety and efficacy of palivizumab in the<br>prevention of severe RSV infection in preterm infants (= 35 wGA), infants with bronchopulmonary dysplasia and infants with hemodynamically significant congenital heart disease in the Russian Federation.;Secondary Objective: Not applicable;Primary end point(s): Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)<br>;Timepoint(s) of evaluation of this end point: Through 30 days following the last injection of palivizumab
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Total number of respiratory syncytial virus (RSV)-hospitalization days<br>• Total respiratory syncytial virus (RSV)-hospitalization days with increased supplemental oxygen requirement<br>• Number of intensive care unit (ICU) admissions during respiratory syncytial virus (RSV)-hospitalization<br>• Total days of respiratory syncytial virus (RSV) intensive care unit (ICU) stay<br>• Total days of mechanical ventilation during hospitalization due to RSV infection;Timepoint(s) of evaluation of this end point: Through 30 days following the last injection of palivizumab