E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe Respiratory Syncytial Virus Infection (RSV) |
|
E.1.1.1 | Medical condition in easily understood language |
Respiratory Tract Infection (RSV) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061603 |
E.1.2 | Term | Respiratory syncytial virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study was to describe the safety and efficacy of palivizumab in the
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. |
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E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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). |
|
E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Through 30 days following the last injection of palivizumab |
|
E.5.2 | Secondary end point(s) |
• Total number of respiratory syncytial virus (RSV)-hospitalization days
• Total respiratory syncytial virus (RSV)-hospitalization days with increased supplemental oxygen requirement
• Number of intensive care unit (ICU) admissions during respiratory syncytial virus (RSV)-hospitalization
• Total days of respiratory syncytial virus (RSV) intensive care unit (ICU) stay
• Total days of mechanical ventilation during hospitalization due to RSV infection |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Through 30 days following the last injection of palivizumab |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end-of-study is defined as the date of the last subject's follow-up contact (100 days
following the final injection of palivizumab). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 10 |