CLINICAL TRIALS PROFILE FOR PALIVIZUMAB
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Biosimilar Clinical Trials for palivizumab
| 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 | >Sponsor | >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. |
| NCT01466062 ↗ | Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions | Completed | AbbVie (prior sponsor, Abbott) | Phase 3 | 2011-08-01 | To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions. |
| NCT02290340 ↗ | A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Health | Completed | MedImmune LLC | Phase 1 | 2015-01-13 | The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants. |
| NCT02325791 ↗ | Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants | Completed | Regeneron Pharmaceuticals | Phase 3 | 2015-07-21 | The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for palivizumab
Condition Name
| Condition Name for palivizumab | |
| Intervention | Trials |
| Respiratory Syncytial Virus Infections | 3 |
| Respiratory Syncytial Virus Infection | 1 |
| Respiratory Syncytial Virus-bronchiolitis | 1 |
| -Unhealthy Children With a History of Prematurity | 1 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for palivizumab
Trials by Country
Clinical Trial Progress for palivizumab
Clinical Trial Phase
Clinical Trial Sponsors for palivizumab
Sponsor Name
