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NCT00628303
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants
Phase 3 trial testing Motavizumab in Wheezing. Withdrawn.
1 February 2011
Quick facts
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 October 2010 |
| Primary completion | 1 February 2011 |
| Estimated completion | 1 December 2011 |
Drugs / interventions tested
- Motavizumab — full drug profile →
- Placebo
Conditions studied
- Wheezing — all drugs for Wheezing →
Sponsor
MedImmune LLC — full company profile →
Who can join
Under 6 Months, any sex, with Wheezing. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The incidence of serious early childhood wheezing episodes
Time frame: Between 2nd and 3rd birthdays
Sponsor's own description
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Motavizumab.
Cingoz O. · · 2009 · cited 25× · PMID 20065632 · DOI 10.4161/mabs.1.5.9496 -
Erratum to: Motavizumab
· 2010 · DOI 10.4161/mabs.2.5.12759
Verify or expand the search:
- PubMed search for NCT00628303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Motavizumab
Trials testing the same drug.
- NCT00435227 — A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) · Phase 2 · terminated
- NCT00421304 — A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory · NA · completed
- NCT00121108 — MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infan · Phase 3 · completed
Other recruiting trials for Wheezing
Currently open trials in the same condition.
- NCT07044128 — Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under · recruiting
- NCT06580600 — PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze · NA · recruiting
- NCT05667701 — Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study · Phase 2 · recruiting
- NCT06603584 — Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital · recruiting
- NCT06311162 — Early Life Intervention in Pediatrics Supported by E-health - SMOKE · NA · recruiting
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)
- Trial protocol + status: ClinicalTrials.gov NCT00628303 (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: 30 July 2012
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/NCT00628303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing