CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
Motavizumab, palivizumab +2 morebiological
Likely dose
Motavizumab, palivizumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00316264
NCT00316264Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab When Administered in the Same Season

MedImmune LLC·interventional·Posted Apr 20, 2006·Updated Dec 11, 2012

In Brief

A Phase 2 clinical trial evaluating Motavizumab, palivizumab, Palivizumab, motavizumab, and 1 other intervention for Respiratory Syncytial Virus Infections and 2 related conditions. Completed, enrolled 260 participants across 19 sites in 3 countries.

Detailed Summary

This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
CountriesAustralia, Chile, New Zealand
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2006
Enrollment StartApr 1, 2006
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.2 years ago

Interventions

Motavizumab, palivizumabbiological

Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.

Palivizumab, motavizumabbiological

Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.

Motavizumabbiological

Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.