A pivotal phase 3 study of MEDI-524 (Numax), an enhanced potency humanized respiratory syncytial virus (RSV) monoclonal antibody, for the prophylaxis of serious RSV disease in high-risk children.

Phase 1

Conditions: Serious respiratory syncytial virus (RSV) disease
MedDRA version: 7.0Level: PTClassification code 10061603

Registration Number: EUCTR2004-000039-27-IS

Lead Sponsor: MedImmune, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5750

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

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

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

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