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Last Updated: December 1, 2021

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CLINICAL TRIALS PROFILE FOR PALIVIZUMAB

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Biosimilar Clinical Trials for palivizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT05121246 ↗ Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis┬« and US-sourced Synagis┬« in Healthy Volunteers. Not yet recruiting mAbxience S.A Phase 1 2022-01-01 Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU Synagis┬« in healthy subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for palivizumab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00014391 ↗ Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation Completed National Cancer Institute (NCI) Phase 3 1999-02-01 RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation. PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.
NCT00014391 ↗ Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation Completed Fred Hutchinson Cancer Research Center Phase 3 1999-02-01 RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation. PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.
NCT00240929 ↗ A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis) Completed MedImmune LLC Phase 2 2002-09-01 A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
NCT00484393 ↗ Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study Completed Fraser Health Phase 4 2007-11-01 This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for palivizumab

Condition Name

Condition Name for palivizumab
Intervention Trials
Respiratory Syncytial Virus Infections 2
Respiratory Syncytial Virus 1
Respiratory Syncytial Virus (RSV) 1
Respiratory Syncytial Virus Infection 1
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Condition MeSH

Condition MeSH for palivizumab
Intervention Trials
Virus Diseases 5
Respiratory Syncytial Virus Infections 4
Infections 3
Infection 2
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Clinical Trial Locations for palivizumab

Trials by Country

Trials by Country for palivizumab
Location Trials
United States 82
United Kingdom 9
Canada 8
Ukraine 7
South Africa 5
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Trials by US State

Trials by US State for palivizumab
Location Trials
California 5
South Carolina 4
New York 4
Florida 3
Wisconsin 3
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Clinical Trial Progress for palivizumab

Clinical Trial Phase

Clinical Trial Phase for palivizumab
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2/Phase 3 1
[disabled in preview] 2
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Clinical Trial Status

Clinical Trial Status for palivizumab
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 1
Recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for palivizumab

Sponsor Name

Sponsor Name for palivizumab
Sponsor Trials
MedImmune LLC 4
mAbxience S.A 2
AbbVie 1
[disabled in preview] 1
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Sponsor Type

Sponsor Type for palivizumab
Sponsor Trials
Industry 12
Other 3
NIH 1
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