E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Serious respiratory syncytial virus (RSV) disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061603 |
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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 |
To compare the safety and efficacy of MEDI-524 to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. |
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E.2.2 | Secondary objectives of the trial |
1. To compare the incidence of medically-attended LRIs between treatment groups 2. To compare the incidence of RSV-specific medically-attended LRI in a subset of patients 3. To compare the frequency and incidence of medically-attended OM infections between treatment groups 4. To compare the frequency of prescribed antibiotics for medically-attended LRI and medically-attended OM infections 5. To describe the trough serum concentrations of MEDI-524 6. To describe the immunogenicity of MEDI-524
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday) with a diagnosis of Chronic Lung Disease of prematurity requiring medical intervention / management (i.e., supplemental oxygen, bronchodilators, or diuretics) within the 6 months before randomization
or
35 weeks gestational age or less at birth and 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
2. Written informed consent obtained from the patient’s parent(s) or legal guardian
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E.4 | Principal exclusion criteria |
Children must have none of the following: 1. Hospitalization at the time of randomization (unless discharge is anticipated within 10 days) 2. Mechanical ventilation or other mechanical support (including CPAP) 3. Life expectancy <6 months 4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) 5. Known renal impairment 6. Known hepatic dysfunction 7. Chronic seizure evolving or unstable or neurologic disorder 8. Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled.) 9. Known immunodeficiency 10. Mother with HIV infection (unless the child has been proven to be not infected) 11. Known allergy to Ig products 12. Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization 13. Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted) 14. Previous receipt of RSV vaccines 15. Participation in other investigational drug product studies
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E.5 End points |
E.5.1 | Primary end point(s) |
The incidence of RSV hospitalization from Study Day 0 through Study Day 150 will be the primary endpoint. Both primary and nosocomial RSV hospitalizations will count as endpoints. In addition, deaths which can be demonstrated to be caused by RSV (by autopsy or clinical history and virologic evidence) will also be considered as primary RSV hospitalization endpoints |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |