Phase 3
N=2,127
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00121108 ↗Enrolled (actual)
2,127
Serious AEs
17.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization — 80; 21 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Motavizumab (Biological); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization |
80; 21 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
686; 1361; 148; 212 | — |
| SECONDARY Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) |
71; 41 | — |
| SECONDARY Number of Participants With Medically Attended-Otitis Media (MA-OM) Events |
275; 532 | — |
| SECONDARY Number of Participants With Frequency of MA-OM Events |
435; 885; 190; 372; 55; 114 | — |
| SECONDARY Number of Participants With Medically Attended Wheezing Episodes |
179; 342; 16; 35 | — |
| SECONDARY Number of Participants With Serious Early Childhood Wheezing Episodes |
90; 190; 16; 35; 66; 144 | — |
| SECONDARY Number of Participants With Frequency of Medically Attended Wheezing Events |
384; 908; 182; 288; 72; 109 | — |
| SECONDARY Mean Trough Serum Concentrations of Motavizumab |
0.003212; 86.46 | — |
| SECONDARY Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose |
0; 3 | — |
| SECONDARY Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose |
0; 3 | — |
Summary
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
Eligibility Criteria
Inclusion Criteria
- 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
- Male or female Native American
- General state of good health
- Written informed consent obtained from the participant's parent(s) or legal guardian
Exclusion Criteria
- Gestational age less than or equal to 35 weeks
- Chronic lung disease of prematurity
- A bleeding diathesis that would preclude IM injections
- Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- A documented wheezing episode before enrollment
- Known renal impairment
- Known hepatic dysfunction
- Clinically significant congenital anomaly of the respiratory tract
- Chronic seizure or evolving or unstable neurologic disorder
- Congenital heart disease (CHD) (children with uncomplicated CHD [e.g., Patent ductus arteriosus, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
- Known immunodeficiency
- Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
- Known allergy to Ig products
- Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) within 3 months prior to randomization
- Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
- Previous receipt of RSV vaccines
- Participation in other investigational drug product studies
- Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
- Inability to complete the study follow-up period through up to 5 years of age
Data sourced from ClinicalTrials.gov (NCT00121108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.