NCT00129766

A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

Completed Phase 3 Results posted Last updated 21 June 2013

What this trial tests

Phase 3 trial testing motavizumab (MEDI-524) in Respiratory Syncytial Virus Infections in 6,635 participants. Completed in 1 May 2006.

Timeline

1 November 2004

Primary endpoint
1 May 2006

1 May 2006

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	6,635
Start date	1 November 2004
Primary completion	1 May 2006
Estimated completion	1 May 2006
Sites	344 locations across United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile

Drugs / interventions tested

• motavizumab (MEDI-524) — full drug profile →
• palivizumab — full drug profile →

Conditions studied

• Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →

Sponsor

MedImmune LLC — full company profile →

Who can join

Under 24 Months, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of RSV Hospitalization (Includes Deaths by RSV)
  Time frame: Days 0 - 150
  RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
• Number of Participants Reporting Any Adverse Events (AEs)
  Time frame: Days 0 - 150
  Number of participants reporting one or more AEs
• Number of Participants Reporting Any Related AEs
  Time frame: Days 0 - 150
  Number of participants reporting one or more AEs considered related to study drug by the investigator
• Number of Participants Reporting Any Serious Adverse Events (SAEs)
  Time frame: Days 0 - 150
  Number of participants reporting one or more SAEs
• Number of Participants Reporting Any Related SAEs
  Time frame: Days 0 - 150
  Number of participants reporting one or more SAEs considered related to study drug by the investigator
• Number of Participants Reporting AEs by Highest Severity Grade
  Time frame: Days 0 - 150
  Adverse events events were graded by severity; Level 1, 2, 3, or 4

Sponsor's own description

The primary objective of this study was to compare the safety and efficacy of motavizumab 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. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody therapies for the prevention and treatment of viral infections.
   Salazar G, Zhang N, Fu TM, An Z. · · 2017 · cited 135× · PMID 29263875 · DOI 10.1038/s41541-017-0019-3
2. Overview of Current Therapeutics and Novel Candidates Against Influenza, Respiratory Syncytial Virus, and Middle East Respiratory Syndrome Coronavirus Infections.
   Behzadi MA, Leyva-Grado VH. · · 2019 · cited 78× · PMID 31275265 · DOI 10.3389/fmicb.2019.01327
3. Motavizumab.
   Cingoz O. · · 2009 · cited 25× · PMID 20065632 · DOI 10.4161/mabs.1.5.9496
4. Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus.
   Verwey C, Madhi SA. · · 2023 · cited 24× · PMID 37097594 · DOI 10.1007/s40259-023-00596-4
5. Innate Immune Components that Regulate the Pathogenesis and Resolution of hRSV and hMPV Infections.
   Andrade CA, Pacheco GA, Gálvez NMS, Soto JA, et al · · 2020 · cited 24× · PMID 32545470 · DOI 10.3390/v12060637
6. Passive Immunoprophylaxis against Respiratory Syncytial Virus in Children: Where Are We Now?
   Rocca A, Biagi C, Scarpini S, Dondi A, et al · · 2021 · cited 23× · PMID 33918185 · DOI 10.3390/ijms22073703
7. Learning from past failures: Challenges with monoclonal antibody therapies for COVID-19.
   Lai SK, McSweeney MD, Pickles RJ. · · 2021 · cited 22× · PMID 33276017 · DOI 10.1016/j.jconrel.2020.11.057
8. Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children: Rationale and Progress to Date.
   Verwey C, Dangor Z, Madhi SA. · · 2024 · cited 15× · PMID 38032456 · DOI 10.1007/s40272-023-00606-6