Who is sponsoring NCT00113490?

NCT00113490 is sponsored by MedImmune LLC.

What drugs are being tested in NCT00113490?

Interventions in NCT00113490: motavizumab (MEDI-524), palivizumab 15 mg/kg.

Is NCT00113490 still recruiting?

NCT00113490 is currently completed. Last updated 3 April 2013.

Are results published for NCT00113490?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-04-03 · How we verify

NCT00113490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

Completed Phase 1/Phase 2 Results posted Last updated 3 April 2013

What this trial tests

Phase 1/Phase 2 trial testing motavizumab (MEDI-524) in Motavizumab Administration for a Second Season for RSV Prophylaxis in 136 participants. Completed in 1 February 2006.

Timeline

1 May 2005

Primary endpoint
1 February 2006

1 February 2006

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	136
Start date	1 May 2005
Primary completion	1 February 2006
Estimated completion	1 February 2006
Sites	6 locations across Brazil, Chile

Drugs / interventions tested

motavizumab (MEDI-524) — full drug profile →
palivizumab 15 mg/kg — full drug profile →

Conditions studied

Motavizumab Administration for a Second Season for RSV Prophylaxis — all drugs for Motavizumab Administration for a Second Season for RSV Prophylaxis →

Sponsor

MedImmune LLC — full company profile →

Who can join

Under 24 Months, any sex, with Motavizumab Administration for a Second Season for RSV Prophylaxis. 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.

Number of Subjects Exhibiting Anti-motavizumab Antibodies
Time frame: Day 0 through 120 days post final dose
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.

Sponsor's own description

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

Publications & conference data

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

Motavizumab.
Cingoz O. · · 2009 · cited 25× · PMID 20065632 · DOI 10.4161/mabs.1.5.9496
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
Clinical research on RSV prevention in children and pregnant women: progress and perspectives.
Gong X, Luo E, Fan L, Zhang W, et al · · 2023 · cited 9× · PMID 38327765 · DOI 10.3389/fimmu.2023.1329426
Erratum to: Motavizumab
· 2010 · DOI 10.4161/mabs.2.5.12759

Verify or expand the search:

Other MedImmune LLC trials

Trials by the same sponsor.

NCT04145193 — Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC · Phase 2 · withdrawn
NCT04522323 — A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma · Phase 1 · active not recruiting
NCT03903718 — Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza · Phase 2 · withdrawn
NCT04261075 — IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors. · Phase 1 · completed
NCT03889275 — A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00113490 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 3 April 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00113490.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing